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510(k) summaries or 510(k) statements for final decisions rendered during October 2013.
TOTAL 510(k)s THIS PERIOD 264 TOTAL WITH SUMMARIES 254 TOTAL WITH STATEMENTS 10
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD October 2014
DEVICE: FLUOR PROTECTOR S IVOCLAR VIVADENT AG 510(k) NO: K131487(Traditional) ATTN: DONNA M HARTNETT PHONE NO : 716 691-2260 175 PINEVIEW DR. SE DECISION MADE: 08-OCT-14 AMHERST NY 14228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERNOVA C5 MRI SYSTEM LIAONING KAMPO MEDICAL SYSTEM CO.,510(k) NO: K131737(Traditional) ATTN: SHAO KAI PHONE NO : 86 414 5555322 NO. 9, YAODU STREET, BENXI ECONOMISE DECISION MADE: 23-OCT-14 BENXI, LIAONING CN 117004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HS NOTA H.S. HOSPITAL SERVICES S.P.A. 510(k) NO: K131925(Traditional) ATTN: LUCIO IMPROTA PHONE NO : 561 477-1671 10147 UMBERLAND PLACE SE DECISION MADE: 10-OCT-14 BOCA RATON FL 33428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIPULSE HOPLUS ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K131987(Traditional) ATTN: ANTJE KATZER PHONE NO : 004 936 417700309 BRUESSELER STR. 10 SE DECISION MADE: 15-OCT-14 JENA, THURINGIA DE 07747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKORE AND MULTIPLE BRANDS TTK PROTECTIVE DEVICES LIMITED (FO510(k) NO: K132490(Abbreviated) ATTN: MANOJ ZACHARIAS PHONE NO : 630 270-2921 2871, COASTAL DR SE DECISION MADE: 20-OCT-14 AURORA IL 60503 510(k) STATEMENT
DEVICE: FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET COOK, INC. 510(k) NO: K132592(Traditional) ATTN: DAVID LEHR PHONE NO : 812 335-3575 750 DANIELS WAY SE DECISION MADE: 09-OCT-14 Blmgtn IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KINGSTON ENDOSCOPIC SURGICAL INSTRUMENTS QINGDAO KINGSTON MEDICAL DEVICES L510(k) NO: K132771(Traditional) ATTN: WU HANHUA PHONE NO : 86 0532 86769190 No.5 Seoul Road Free Trade Zone SE DECISION MADE: 28-OCT-14 QINGDAO, SHANDONG CN 266555 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVAPACS NOVARAD CORP. 510(k) NO: K132853(Traditional) ATTN: AMY HOFFMAN PHONE NO : 801 642-1001 752 E 1180 S Ste 200 SE DECISION MADE: 30-OCT-14 American Fork UT 84003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LED CURING LIGHT MONITEX INDUSTRIAL CO., LTD. 510(k) NO: K133040(Traditional) ATTN: SHU-LUNG WANG PHONE NO : 886 2 29993869 6F, 70 SEC. 1 GUANG-FU ROAD SAN-CHSE DECISION MADE: 07-OCT-14 NEW TAIPEI CITY TW 241 58 510(k) STATEMENT
DEVICE: CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES CODENT TECHNICAL INDUSTRY CO., LTD510(k) NO: K133069(Traditional) ATTN: CHIN-TING WEN PHONE NO : 886 769555 33 5F., No.90, Luke 5th Rd., Luzhu DiSE DECISION MADE: 24-OCT-14 Kaohsiung City TW 82151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6" MEDTRONIC, INC. 510(k) NO: K133157(Traditional) ATTN: JESSICA SIXBERRY PHONE NO : 763 514-9849 7611 NORTHLAND DRIVE SE DECISION MADE: 23-OCT-14 MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-FIT EF-1280 EMS MACHINE FIT-PRO KFT LTD. 510(k) NO: K133225(Traditional) ATTN: RHONDA ALEXANDER, M.S., M.PPHONE NO : 757 224-0177 144 RESEARCH DRIVE SE DECISION MADE: 24-OCT-14 HAMPTON VA 23666 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM GENESYS SPINE 510(k) NO: K133245(Traditional) ATTN: WILLIAM W SOWERS PHONE NO : 512 381-7080 1250 CAPITAL OF TEXAS HWY SOUTH BUSE DECISION MADE: 08-OCT-14 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AERONEB SOLO; AERONEB SOLO ADAPTER AEROGEN LTD 510(k) NO: K133360(Traditional) ATTN: MARTIN CREHAN PHONE NO : 353 91 540459 IDA BUSINESS PARK, DANGAN SE DECISION MADE: 17-OCT-14 GALWAY IE GALWAY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NDX DORSAL APPLIANCE INSTITUTE FOR QUALITY RESOURCE MAN510(k) NO: K133390(Traditional) ATTN: LEAH AMIR, MS, MHA PHONE NO : 877 997-3360 1 CITY PLACE DRIVE, STE 285 SE DECISION MADE: 16-OCT-14 ST. LOUIS MO 63131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONESTEP CPR II MULTI-FUNCTION ELECTRODE BIO-DETEK, INC. 510(k) NO: K133441(Traditional) ATTN: SHANNON DUHAMEL PHONE NO : 978 421-9574 269 MILL ROAD SE DECISION MADE: 10-OCT-14 CHELMSFORD MA 01824-4105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIEZOMED W & H DENTALWERK BUERMOOS GMBH 510(k) NO: K133488(Traditional) ATTN: ANJA LINDNER PHONE NO : 43 627 46236297 IGNAZ-GLASER-STRASSE 53 SE DECISION MADE: 16-OCT-14 BUERMOOS, SALZBURG AT 5111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO CT SINGLE SOURCE DUAL ENERGY SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133677(Traditional) ATTN: KIMBERLY MANGUM PHONE NO : 610 448-4912 51 VALLEY STREAM PKWY. SE DECISION MADE: 16-OCT-14 MALVERN PA 19355-1406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VC150 VITAL SIGNS MONITOR INNOKAS YHTYMA 510(k) NO: K133810(Traditional) ATTN: TIINA VETELAINEN PHONE NO : 358 8 5623100 TARJUSOJANTIE 12 SE DECISION MADE: 30-OCT-14 KEMPELE, OULU FI 90440 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANTERA CLINICAL ANALYZER LIPOSCIENCE 510(k) NO: K133849(Special) ATTN: SUZETTE WARNER PHONE NO : 919 256-1326 2500 SUMMER BLVD. SE DECISION MADE: 22-OCT-14 RALEIGH NC 27616 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MSA100 PEAK FLOW METER BEIJING M&B ELECTRONIC INSTRUMENTS510(k) NO: K133975(Traditional) ATTN: MIKE GU PHONE NO : 86 20 62321333 7TH FLOOR, JINGUI BUSINESS BUILDINSE DECISION MADE: 03-OCT-14 GUANGZHOU, GUANGDONG CN 510420 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IEVA REHABILITATIVE POSITIONAL DEVICE REMENDIUM LABS, LLC 510(k) NO: K133990(Traditional) ATTN: YOLANDA LORIE PHONE NO : 386 717-4360 340 EAST PARKER ROAD SE DECISION MADE: 09-OCT-14 BATON ROUGE LA 70803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL MEDTEK LIGHTING 510(k) NO: K134009(Traditional) ATTN: SUSAN ANTHONEY-DE WET PHONE NO : 865 982-5552 2424 DEMPSTER DRIVE SE DECISION MADE: 15-OCT-14 CORALVILLE IA 52241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM Terumo Cardiovascular Systems Corp510(k) NO: K140008(Traditional) ATTN: GARRY COURTNEY PHONE NO : 800 262-3304 125 BLUE BALL RD. SE DECISION MADE: 31-OCT-14 ELKTON MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPERQ ACS-100 SYSTEM BSP-BIIOLOGICAL SIGNAL PROCESSING,510(k) NO: K140020(Traditional) ATTN: AHAVA STEIN PHONE NO : 972 976 70002 20 HATA’ AS STR., SUITE 102 SE DECISION MADE: 28-OCT-14 KFAR SABA IL 44425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT CORK MEDICAL PRODUCTS LLC 510(k) NO: K140022(Traditional) ATTN: JON SPEER PHONE NO : 765 315-2736 PO BOX 1784 SE DECISION MADE: 24-OCT-14 MARTINSVILLE IN 46151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELEVATION PDG PRODUCT DESIGN GROUP, INC. 510(k) NO: K140023(Traditional) ATTN: EDWARD A KROLL PHONE NO : 440 546-9810 5905 FAWN LANE SE DECISION MADE: 16-OCT-14 CLEVELAND OH 44141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES Pegavision Corporation 510(k) NO: K140025(Traditional) ATTN: PENNY NORTHCUTT PHONE NO : 886 332 98808 174 WATERCOLOR WAY, SUITE 103-403 SE DECISION MADE: 15-OCT-14 SANTA ROSA BEACH FL 32459 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KJ EXTERNAL IMPLANT SYSTEM KJ MEDITECH CO., LTD. 510(k) NO: K140051(Traditional) ATTN: Priscilla Chung PHONE NO : 714 202-5789 2651 E CHAPMAN AVE STE 110 SE DECISION MADE: 30-OCT-14 FULLERTON CA 92831 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: J2I IMPLANT SYSTEM KJ MEDITECH CO., LTD. 510(k) NO: K140052(Traditional) ATTN: Priscilla Chung PHONE NO : 714 202-5789 2651 E CHAPMAN AVE STE 110 SE DECISION MADE: 30-OCT-14 FULLERTON CA 92831 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER FSC LABORATORIES, INC. 510(k) NO: K140062(Traditional) ATTN: PAUL DRYDEN PHONE NO : 239 498-2155 6000 Fairview Rd. Suite 600 SE DECISION MADE: 03-OCT-14 Charlotte NC 28210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPIC 10 BIOLASE, INC. 510(k) NO: K140120(Traditional) ATTN: COLLEEN BOSWELL PHONE NO : 949 226-8470 4 CROMWELL SE DECISION MADE: 10-OCT-14 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM Teleflex Medical, Inc. 510(k) NO: K140197(Traditional) ATTN: HOLLY KORNEGAY PHONE NO : 919 433-4918 2917 WECK DR. PO BOX 12600 SE DECISION MADE: 21-OCT-14 RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM Teleflex Medical, Inc. 510(k) NO: K140205(Traditional) ATTN: HOLLY KORNEGAY PHONE NO : 919 433-4918 2917 WECK DR. PO BOX 12600 SE DECISION MADE: 23-OCT-14 RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO PHADIA US INC. 510(k) NO: K140225(Traditional) ATTN: MARTIN MANN PHONE NO : 497 614 7805173 MUNZINGER STRASSE 7 SE DECISION MADE: 27-OCT-14 FREIBURG IM BREISGAU DE 79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AILERON INTERSPINOUS FIXATION SYSTEM LIFE SPINE, INC 510(k) NO: K140236(Traditional) ATTN: RANDY LEWIS PHONE NO : 847 884-6117 2401 W. HASSELL RD SUITE 1535 SE DECISION MADE: 20-OCT-14 HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LONG PULSE ND: YAG LASER SYSTEM ADVANCED TECHNOLOGY LASER CO., LTD510(k) NO: K140249(Traditional) ATTN: Diana Hong PHONE NO : 86 21 22815850 P.O. BOX 120-119 SE DECISION MADE: 08-OCT-14 SHANGHAI CN 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVERSAL DIGITAL INTERFACE 2, UDI 2 MERIDIAN MEDICAL SYSTEMS, LLC 510(k) NO: K140251(Traditional) ATTN: LARRY CORNELL PHONE NO : 440 287-6801 325 HARRIS DRIVE SE DECISION MADE: 22-OCT-14 AURORA OH 44202 510(k) STATEMENT
DEVICE: SIMPLE T YOUTH NASAL MASK RESPIRONICS, INC. 510(k) NO: K140268(Abbreviated) ATTN: COLLEEN WITT PHONE NO : 724 387-4780 1001 MURRY RIDGE LN. SE DECISION MADE: 20-OCT-14 MURRYSVILLE PA 15668 510(k) STATEMENT
DEVICE: TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM ADIN DENTAL IMPLANTS SYSTEMS LTD. 510(k) NO: K140293(Traditional) ATTN: NISSIM SHAKED PHONE NO : 972 491161 52 ALON TAVOR INDUSTRIAL ZONE SE DECISION MADE: 31-OCT-14 POB 1128 AFULA ELIT IL 1811101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLY SLICK PERSONAL LUBRICATING LOTION SIMPLY SOLUTIONS, LLC 510(k) NO: K140304(Third Party – Traditional) ATTN: JOHN GOEPFERT PHONE NO : 608 563-5555 2949 VENTURE DR., STE 170 SE DECISION MADE: 07-OCT-14 JANESVILLE WI 53546-8501 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: CRANIOPLUG OSSDSIGN AB 510(k) NO: K140309(Traditional) ATTN: DAVID WEISSBURG PHONE NO : 608 770-0223 808 WILLIAMSON ST. SUITE 402 SE DECISION MADE: 03-OCT-14 MADISON WI 53703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COROENT TI-C SYSTEM NUVASIVE, INC. 510(k) NO: K140319(Traditional) ATTN: JEREMY MARKOVICH PHONE NO : 858 309-3783 7475 LUSK BLVD SE DECISION MADE: 09-OCT-14 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLOX2 TISSUE EXPANDERS SPECIALTY SURGICAL PRODUCTS, INC. 510(k) NO: K140383(Traditional) ATTN: SHERRY NULL PHONE NO : 406 961-0102 1123 NORTH U.S. HWY. 93 SE DECISION MADE: 28-OCT-14 VICTOR MT 59875 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRA EXTERNAL FIXATION SYSTEM ASCENSION ORTHOPEDIC 510(k) NO: K140463(Traditional) ATTN: STEVE BROWN PHONE NO : 435 7741535 560 W. GOLF COURSE ROAD SE DECISION MADE: 10-OCT-14 PROVIDENCE UT 84332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER STERILUCENT, INC 510(k) NO: K140464(Traditional) ATTN: PETER KALKBRENNER PHONE NO : 612 767-3253 1400 MARSHALL STREET NE SE DECISION MADE: 31-OCT-14 MINNEAPOLIS MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEX-MT + EMSI 510(k) NO: K140467(Traditional) ATTN: CHERITA JAMES PHONE NO : 703 562-9800 257 815 KING STREET STE 206 SE DECISION MADE: 07-OCT-14 ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER OBERON GMBH FIBER TECHNOLOGIES 510(k) NO: K140470(Traditional) ATTN: ARMIN KAUS PHONE NO : 480 598-4090 7404 W. DETROIT STREET, STE 140 SE DECISION MADE: 15-OCT-14 CHANDLER AZ 85226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONASTENT TRACHEAL / BRONCHIAL ENDOCHOICE, INC. 510(k) NO: K140472(Traditional) ATTN: Bosmat Friedman PHONE NO : 647 975 3974 1208-12 ROCKFORD RD. SE DECISION MADE: 17-OCT-14 TORONTO, ON CA M2R 3A2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELIA SCL-70S IMMUNOASSAY PHADIA GMBH 510(k) NO: K140493(Traditional) ATTN: MARTIN R MANN PHONE NO : 269 492-1957 4169 COMMERCIAL AVE SE DECISION MADE: 30-OCT-14 PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electro Auricular Device NAVIGANT CONSULTING, INC. 510(k) NO: K140530(Traditional) ATTN: COLLEEN HITTLE PHONE NO : 317 228-8730 30 S WACKER DRIVE SUITE 3100 SE DECISION MADE: 02-OCT-14 CHICAGO IL 60606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K140543(Traditional) ATTN: MICHAELA RIVKOWICH PHONE NO : 801 208-4196 1600 WEST MERIT PKWY. SE DECISION MADE: 16-OCT-14 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNESIS PEEK TL CAGE BK MEDITECH CO., LTD. 510(k) NO: K140577(Traditional) ATTN: ELAINE DUNCAN PHONE NO : 715 549-6035 PO BOX 560 SE DECISION MADE: 01-OCT-14 STILLWATER MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT CEDIC S.R.L. 510(k) NO: K140581(Traditional) ATTN: ROGER GRAY PHONE NO : 39 06 5782665 PIAZZA ALBANIA, 10 SE DECISION MADE: 17-OCT-14 ROME IT 00153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASTROGLIDE SENSUAL STRAWBERRY BIOFILM, INC. 510(k) NO: K140590(Traditional) ATTN: Sherry Castello PHONE NO : 760 7279030 3225 Executive Rdg SE DECISION MADE: 30-OCT-14 VISTA CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC DIMA ITALIA SRL 510(k) NO: K140598(Traditional) ATTN: DARIO BASCIU PHONE NO : 39 051568 857 via Coriolano Vighi, 29 SE DECISION MADE: 16-OCT-14 Bologna IT 40133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC DIMA ITALIA SRL 510(k) NO: K140605(Traditional) ATTN: DARIO BASCIU PHONE NO : 39 051568 857 via Coriolano Vighi, 29 SE DECISION MADE: 03-OCT-14 Bologna IT 40133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MECA XPRESSFISH ADVANDX, INC. 510(k) NO: K140619(Traditional) ATTN: RON EISENWINTER PHONE NO : 781 376-0009 1027 400 TradeCenter Suite 6990 SE DECISION MADE: 10-OCT-14 WOBURN MA 01801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP) LUMINEX MOLECULAR DIAGNOSTICS, INC510(k) NO: K140647(Traditional) ATTN: Tina Ip PHONE NO : 416 593 4323 439 UNIVERSITY AVE. SE DECISION MADE: 24-OCT-14 TORONTO, ONTARIO CA M5G 1Y8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLINPRO PROPHY POWDER 3M DEUTSCHLAND GMBH 510(k) NO: K140684(Traditional) ATTN: DESI W SOEGIARTO PHONE NO : 49 815 27001169 ESPE PLATZ SE DECISION MADE: 24-OCT-14 SEEFELD DE D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MPI – MOLECULAR PRECISION IMPLANT, CIP – CYLINDRICAL PRECISION IMPLANT, OPI – ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PR DITRON PRECISION LTD 510(k) NO: K140728(Traditional) ATTN: TALI HAZAN PHONE NO : 972 505 292304 RAMOT NAFTALI M.P UPPER GALILLEE SE DECISION MADE: 17-OCT-14 RAMOT NAFTALI IL 13830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM COOPER SURGICAL, INC. 510(k) NO: K140754(Traditional) ATTN: TIM LOHNES PHONE NO : 203 922-0105 8211 80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 23-OCT-14 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HALO AMBULATORY INFUSION SYSTEM ZYNO MEDICAL LLC. 510(k) NO: K140783(Abbreviated) ATTN: MEI ZHANG PHONE NO : 508 650-2008 205 177 PINE ST SE DECISION MADE: 17-OCT-14 NATICK MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ITCLAMP 50 INNOVATIVE TRAUMA CARE INC 510(k) NO: K140805(Traditional) ATTN: RICHARD WAITE PHONE NO : 210 582-5850 1932 3463 MAGIC DR. SUITE 120 SE DECISION MADE: 09-OCT-14 SAN ANTONIO TX 78229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JUGGERKNOT MINI SOFT ANCHOR BIOMET SPORTS MEDICINE 510(k) NO: K140908(Traditional) ATTN: GARY BAKER PHONE NO : 574 3711088 56 EAST BELL DRIVE SE DECISION MADE: 02-OCT-14 WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVERSAL NAVIGATION INSTRUMENTS MEDOS INTERNATIONAL SARL 510(k) NO: K140927(Traditional) ATTN: KIRSTEN LEHMULLER PHONE NO : 508 828-3291 325 Paramount Drive SE DECISION MADE: 24-OCT-14 Raynham MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z1 CPAP SYSTEM HUMAN DESIGN MEDICAL, LLC 510(k) NO: K140929(Traditional) ATTN: MAUREEN O’CONNELL PHONE NO : 978 207-1245 5 TIMBER LANE SE DECISION MADE: 17-OCT-14 NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTOM-I ALERT 11 HEALTH AND TECHNOLOGIES LLC 510(k) NO: K140938(Traditional) ATTN: E J SMITH PHONE NO : 888 729-9674 1468 Harwell Avenue SE DECISION MADE: 10-OCT-14 Crofton MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCESS INDICATOR TAPE FOR STEAM STERILIZATION CANADIAN TECHNICAL TAPE, LTD. 510(k) NO: K140940(Traditional) ATTN: GARY SOCOLA PHONE NO : 505 743-1935 125 HIGHPOWER ROAD SE DECISION MADE: 27-OCT-14 ROCHESTER NY 14623 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IONOSTAR MOLAR VOCO GMBH 510(k) NO: K140993(Traditional) ATTN: T GERKENSMEIER PHONE NO : 494 721 719200 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 20-OCT-14 CUXHAVEN DE D-27472 510(k) STATEMENT
DEVICE: FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM FOLSOM METAL PRODUCTS, INC. DBA FR510(k) NO: K141106(Traditional) ATTN: KEVIN ETHERIDGE PHONE NO : 205 733-0901 153A CAHABA VALLEY PARKWAY SE DECISION MADE: 10-OCT-14 PELHAM AL 35124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE HANDPIECE HEADQUARTERS 510(k) NO: K141125(Traditional) ATTN: TINA STEFFANIE-OAK PHONE NO : 717 335-7230 4150 620 S. PLACENTIA AVE. SE DECISION MADE: 23-OCT-14 PLACENTIA CA 92870 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE UNISIS CORP. 510(k) NO: K141126(Traditional) ATTN: DIANE RUTHERFORD PHONE NO : 972 480-9554 1201 RICHARDSON DRIVE, SUITE 280 SE DECISION MADE: 31-OCT-14 RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER ZOLL CIRCULATION 510(k) NO: K141139(Traditional) ATTN: SUSAN NORIEGA PHONE NO : 408 419-2988 2000 Ringwood Ave SE DECISION MADE: 03-OCT-14 San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTAGE STEVENSON INDUSTRIES, INC. 510(k) NO: K141152(Traditional) ATTN: SERRAH NAMINI PHONE NO : 805 426-3544 780 CHAMBERS LANE SUITE 200 SE DECISION MADE: 17-OCT-14 SIMI VALLEY CA 93065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR A & D CO., LTD. 510(k) NO: K141160(Special) ATTN: JERRY WANG PHONE NO : 408 518-5113 1756 AUTOMATION PARKWAY SE DECISION MADE: 07-OCT-14 SAN JOSE CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MATRIXWAVE MMF SYSTEM SYNTHES (USA) PRODUCTS LLC 510(k) NO: K141165(Traditional) ATTN: Damon Lees PHONE NO : 610 718-5608 1302 WRIGHTS LANE EAST SE DECISION MADE: 17-OCT-14 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENOVOCATH RC120 RENOVORX, INC. 510(k) NO: K141175(Traditional) ATTN: RON S WARREN PHONE NO : 408 400-0856 7775 N. MATHILDA AVE, STE 100 SE DECISION MADE: 24-OCT-14 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PADI-LOCK PADI-LOCK, LLC 510(k) NO: K141200(Traditional) ATTN: MARIA GRIFFIN PHONE NO : 516 482-9001 55 NORTHERN BLVD, STE 200 SE DECISION MADE: 02-OCT-14 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR A & D CO., LTD. 510(k) NO: K141201(Special) ATTN: JERRY WANG PHONE NO : 408 518-5113 1756 AUTOMATION PARKWAY SE DECISION MADE: 08-OCT-14 SAN JOSE CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVABONE BIOACTIVE STRIP NovaBone Products, LLC 510(k) NO: K141207(Traditional) ATTN: Lisa Simpson PHONE NO : 386 462-7661 216 13510 NW US Highway 441 SE DECISION MADE: 31-OCT-14 Alachua FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS PRISMATIK DENTALCRAFT, INC. 510(k) NO: K141211(Traditional) ATTN: MARIA HATEGAN PHONE NO : 949 225-1241 2212 DUPONT DRIVE, SUITE P SE DECISION MADE: 22-OCT-14 IRVINE CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR LARES RESEARCH, INC. 510(k) NO: K141221(Abbreviated) ATTN: JASON ORGAIN PHONE NO : 530 345-1767 295 LOCKHEED AVE. SE DECISION MADE: 28-OCT-14 CHICO CA 95973 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLIDE DEVICE HOME SKINOVATIONS LTD. 510(k) NO: K141242(Traditional) ATTN: AHAVA STEIN PHONE NO : 972 976 70002 20 HATA’AS STR., SUITE 102 SE DECISION MADE: 17-OCT-14 KFAR SABA IL 44425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORUM GLAUCOMA WORKPLACE CARL ZEISS MEDITEC AG 510(k) NO: K141297(Traditional) ATTN: MANDY AMBRECHT PHONE NO : 925 557-4561 5160 HACIENDA DRIVE SE DECISION MADE: 03-OCT-14 DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILUCENT PROCESS CHALLENGE DEVICE STERILUCENT, INC 510(k) NO: K141312(Traditional) ATTN: PETER KALKBRENNER PHONE NO : 612 767-3253 1400 MARSHALL STREET NE SE DECISION MADE: 31-OCT-14 MINNEAPOLIS MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA TOPCON CORP. 510(k) NO: K141325(Traditional) ATTN: MAUREEN O’CONNELL PHONE NO : 978 207-1245 5 TIMBER LANE SE DECISION MADE: 23-OCT-14 NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS) BIOMET, INC. 510(k) NO: K141331(Traditional) ATTN: TRACY BICKEL JOHNSON PHONE NO : 574 372-1761 56 EAST BELL DRIVE PO BOX 587 SE DECISION MADE: 27-OCT-14 WARSAW IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPEL APD DRAINAGE CATHETER SYSTEM BOSTON SCIENTIFIC CORP. 510(k) NO: K141335(Traditional) ATTN: MATT BEAUCHANE PHONE NO : 763 494-1789 ONE SCIMED PLACE SE DECISION MADE: 17-OCT-14 MAPLE GROVE MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE ASAHI INTECC CO., LTD. 510(k) NO: K141339(Traditional) ATTN: CANDACE CEDERMAN PHONE NO : 410 674-2060 5523 RESEARCH PARK DRIVE, SUITE 20SE DECISION MADE: 23-OCT-14 BALTIMORE MD 21228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM BOSTON SCIENTIFIC CORP. 510(k) NO: K141344(Traditional) ATTN: MATT BEAUCHANE PHONE NO : 763 494-1789 ONE SCIMED PLACE SE DECISION MADE: 17-OCT-14 MAPLE GROVE MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMERGE MEDICAL IM NAIL SYSTEM EMERGE MEDICAL 510(k) NO: K141347(Traditional) ATTN: MICHELLE POTVIN PHONE NO : 720 459-6392 720 S. COLORADO BLVD. SUITE 550-S SE DECISION MADE: 02-OCT-14 DENVER CO 80246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDC INTERLOCKING DETACHABLE COIL Boston Scientific Corporation 510(k) NO: K141378(Traditional) ATTN: LIZ JOHNSTON PHONE NO : 763 494-1676 ONE SCIMED PLACE SE DECISION MADE: 08-OCT-14 MAPLE GROVE MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM STIMWAVE TECHNOLOGIES INCORPORATED510(k) NO: K141399(Traditional) ATTN: Elizabeth Greene PHONE NO : 800 965-5134 420 Lincoln Rd Suite 365 SE DECISION MADE: 10-OCT-14 Miami Beach FL 33139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL BIOMET, INC. 510(k) NO: K141407(Traditional) ATTN: JULIE GANTENBERG, M.S. PHONE NO : 574 377-8133 56 EAST BELL DR. BOX 587 SE DECISION MADE: 27-OCT-14 WARSAW IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOOD PRESSURE MONITOR SHENZHEN PUMP MEDICAL SYSTEM CO., 510(k) NO: K141416(Traditional) ATTN: XIE QIONGYU PHONE NO : 086 075526 710795 2/F WEST, M-7 SINOSTEEL BUILDING, SE DECISION MADE: 09-OCT-14 NANSHAN DISTRICT, SHENZHEN, GUANGD510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS FOLATE III Roche Diagnostics 510(k) NO: K141426(Traditional) ATTN: KELLI TURNER PHONE NO : 317 521-4515 9115 HAGUE ROAD SE DECISION MADE: 17-OCT-14 INDIANAPOLIS IN 46250-0416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE FIAGON NAVIGATION – EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL FIAGON GMBH 510(k) NO: K141456(Traditional) ATTN: DIRK MUCHA PHONE NO : 49 3302 2012124 NEUENDORFSTRASSE 23B SE DECISION MADE: 08-OCT-14 HENNIGSDORF DE 16761 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0 TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K141459(Traditional) ATTN: ORLANDO TADEO PHONE NO : 714 669-7459 2441 MICHELLE DRIVE SE DECISION MADE: 28-OCT-14 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLITAIRE 2 REVASCULARIZATION DEVICE MICRO THERAPEUTICS, INC. D/B/A EV3510(k) NO: K141491(Traditional) ATTN: LARRY BOUCHER PHONE NO : 948 837-3700 9775 TOLEDO WAY SE DECISION MADE: 22-OCT-14 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY ORTHOCON, INC. 510(k) NO: K141502(Traditional) ATTN: Howard Schrayer PHONE NO : 914 357-2600 1 Bridge St Ste 121 SE DECISION MADE: 03-OCT-14 Irvington NY 10533 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) ECO MEDI GLOVE SDN. BHD 510(k) NO: K141510(Traditional) ATTN: SURESH KUMAR PHONE NO : 603 602 83033 LOT 23826, JALAN TEMBAGA KUNING, KSE DECISION MADE: 07-OCT-14 TAIPING MY 34600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES APEX MEDICAL CORP. 510(k) NO: K141522(Traditional) ATTN: ALAN CHANG PHONE NO : 886 2 22685568 NO. 9, MIN SHENG ST., TU-CHENG, SE DECISION MADE: 06-OCT-14 NEW TAIPEI CITY TW 23679 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KUBTEC X250 KUB TECHNOLOGIES, INC 510(k) NO: K141539(Traditional) ATTN: VIKRAM BUTANI PHONE NO : 203 364-8544 270 ROWE AVENUE, UNIT E SE DECISION MADE: 29-OCT-14 MILFORD CT 06461 510(k) STATEMENT
DEVICE: NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS ) Covidien LLC 510(k) NO: K141542(Traditional) ATTN: MIA M WARE PHONE NO : 303 305-2750 6135 Gunbarrel Ave SE DECISION MADE: 02-OCT-14 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM ZIMMER DENTAL INC. 510(k) NO: K141544(Traditional) ATTN: CHRISTINA BOYDSTON PHONE NO : 760 929-4300 1900 ASTON AVE. SE DECISION MADE: 22-OCT-14 CARLSBAD CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE ETHICON, INC. 510(k) NO: K141560(Traditional) ATTN: SUSAN LIN PHONE NO : 908 218-2256 P.O. BOX 151 ROUTE 22 WEST SE DECISION MADE: 23-OCT-14 SOMERVILLE NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "OPTON PRO" ZIMMER MEDIZINSYSTEMS GMBH 510(k) NO: K141564(Third Party – Traditional) ATTN: ARMIN PETRASCHKA PHONE NO : 497 319761 140 JUNKERSSTRASSE 9 SE DECISION MADE: 24-OCT-14 NEU-ULM DE 89231 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: IMPLANT STUDIO 3SHAPE MEDICAL A/S 510(k) NO: K141570(Traditional) ATTN: HANNE NIELSEN PHONE NO : 457 027262 0 HOLMENS KANAL 7 SE DECISION MADE: 31-OCT-14 COPENHAGEN K DK DK-1060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE ECO MEDI GLOVE SDN. BHD 510(k) NO: K141579(Traditional) ATTN: SURESH KUMAR PHONE NO : 603 602 83033 LOT 23826, JALAN TEMBAGA KUNING, KSE DECISION MADE: 17-OCT-14 TAIPING, PERAK MY 34600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM Boston Scientific Corporation 510(k) NO: K141584(Traditional) ATTN: THOMAS HIRTE PHONE NO : 508 683-4454 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 16-OCT-14 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT PIONEER SURGICAL TECHNOLOGY, INC. 510(k) NO: K141600(Traditional) ATTN: SARAH MCINTYRE PHONE NO : 916 225-5861 375 RIVER PARK CIRCLE SE DECISION MADE: 17-OCT-14 MARQUETTE MI 49855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultra Silver Dressings MILLIKEN HEALTHCARE PRODUCTS, LLC 510(k) NO: K141603(Special) ATTN: GORDON MACFARLANE PHONE NO : 919 873-8962 62 FOREST STREET,SUITE300 SE DECISION MADE: 22-OCT-14 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K141604(Traditional) ATTN: LILA JOE PHONE NO : 800 3963133876 1800 PYRAMID PLACE SE DECISION MADE: 21-OCT-14 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM ECO MEDI GLOVE SDN BHD 510(k) NO: K141623(Traditional) ATTN: SURESH KUMAR PHONE NO : 603 602 83033 LOT 23826, JALAN TEMBAGA KUNING, KSE DECISION MADE: 07-OCT-14 TAIPING MY 34600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSITITRE SUSCEPTIBILITY PLATES Thermo Fisher Scientific 510(k) NO: K141651(Traditional) ATTN: Cynthia Knapp PHONE NO : 800 871-8909 4117 1 Thermo Fisher Way SE DECISION MADE: 21-OCT-14 Oakwood Village OH 44146 510(k) STATEMENT
DEVICE: LIGHT SCALPEL LIGHT SCALPEL LLC 510(k) NO: K141658(Traditional) ATTN: DAVID WALTERS PHONE NO : 425 368-1588 16932 WOODINIVILLE-REDMOND RD NE, SE DECISION MADE: 22-OCT-14 WOODINIVILLE WA 98072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRISM ZIRCONIA, ST-98 A & D DENTAL INNOVATIONS 510(k) NO: K141659(Traditional) ATTN: YOONHO JUN PHONE NO : 888 374-5134 9308 EVENING PRIMROSE PATH SE DECISION MADE: 09-OCT-14 AUSTIN TX 78750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAWALUTION SKIN AND WOUND CLEANSER NAWA HEILMITTEL GMBH 510(k) NO: K141660(Traditional) ATTN: ALLYSON B MULLEN PHONE NO : 202 737-9639 700 THIRTEENTH ST, N.W. SE DECISION MADE: 31-OCT-14 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFE’N’SOUND STAKED PASSIVE DELIVERY SYSTEM – CONE VERSION REXAM HEALTHCARE 510(k) NO: K141664(Abbreviated) ATTN: BEATRICE GRAND DEMARS PHONE NO : 334 7495 2915 20 AVENUE DE LA GARE SE DECISION MADE: 02-OCT-14 LA VERPILLIERE FR 38292 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY SMITH MEDICAL ASD, INC. 510(k) NO: K141686(Traditional) ATTN: JIM JOHNSON PHONE NO : 651 628-7264 1265 GREY FOX ROAD SE DECISION MADE: 28-OCT-14 ST. PAUL MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASSEN COLOR VASSEN CO., LTD. 510(k) NO: K141699(Traditional) ATTN: BRET ANDRE PHONE NO : 503 372-5226 474 NE 61ST PL. SE DECISION MADE: 07-OCT-14 HILLSBORO OR 97124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM GENORAY CO., LTD. 510(k) NO: K141700(Traditional) ATTN: KAITLYNN MIN PHONE NO : 714 289-8020 3002 DOW AVENUE, SUITE 420 SE DECISION MADE: 31-OCT-14 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVASHIELD INJECTABLE NASAL PACKING AND STENT MEDTRONIC INC. 510(k) NO: K141704(Traditional) ATTN: RISHI SINHA PHONE NO : 269 903-4373 6743 SOUTHPOINT DRIVE NORTH SE DECISION MADE: 06-OCT-14 JACKSONVILLE FL 32259 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASHAPE SYSTEM SYNERON MEDICAL LTD. 510(k) NO: K141708(Traditional) ATTN: JANICE M HOGAN PHONE NO : 617 863-5520 1835 MARKET ST, 29TH FLOOR SE DECISION MADE: 06-OCT-14 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTGRAFT 200 SYSTEM INGENERON, INC. 510(k) NO: K141713(Traditional) ATTN: ANITA KADALA PHONE NO : 713 440-9900 8205 El Rio St SE DECISION MADE: 28-OCT-14 Houston TX 77054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K141714(Traditional) ATTN: VAL MYLES PHONE NO : 901 290-5162 1023 CHERRY ROAD SE DECISION MADE: 24-OCT-14 MEMPHIS TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UPCERA COLORING LIQUID (I AND II ) LIAONING UPCERA CO.,LTD 510(k) NO: K141723(Traditional) ATTN: CHARLES SHEN PHONE NO : 608 217-9358 853 DORCHESTER LN, SUITE-B SE DECISION MADE: 22-OCT-14 NEW MILFORD NJ 07646 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK LIAONING UPCERA CO.,LTD 510(k) NO: K141724(Traditional) ATTN: CHARLES SHEN PHONE NO : 608 217-9358 853 DORCHESTER LN, SUITE-B SE DECISION MADE: 22-OCT-14 NEW MILFORD NJ 07646 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEPHROS DSU-H, NEPHROS SSU-H NEPHROS, INC. 510(k) NO: K141731(Traditional) ATTN: JAMES SUMMERTON PHONE NO : 201 343-5202 41 GRAND AVE SE DECISION MADE: 24-OCT-14 River Edge NJ 07661 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESIDUAL LIMB LENGTHENING SYSTEM ELLIPSE TECHNOLOGIES INC. 510(k) NO: K141739(Traditional) ATTN: REBECCA SHELBURNE PHONE NO : 949 837-3600 13900 ALTON PKWY STE 123 SE DECISION MADE: 07-OCT-14 IRVINE CA 92618-0000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARDO CARUM AND CALYPSO POWERED BREAST PUMPS ARDO MEDICAL AG 510(k) NO: K141742(Traditional) ATTN: YARMELA PAVLOVIC PHONE NO : 267 675-4601 1835 MARKET STREET, 29TH FLOOR SE DECISION MADE: 17-OCT-14 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT RADIOLOGY SOLUTIONS LLC 510(k) NO: K141743(Traditional) ATTN: DANIEL KAMM, P.E. PHONE NO : 239 234-1735 8870 RAVELLO CT. SE DECISION MADE: 03-OCT-14 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IQQA-BODYIMAGING SOFTWARE EDDA TECHNOLOGY 510(k) NO: K141745(Traditional) ATTN: DANIEL KAMM PHONE NO : 239 234-1735 5 Independence Way SE DECISION MADE: 31-OCT-14 Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUARIUS NASAL FEEDING TUBE DEGANIA SILICONE, LTD. 510(k) NO: K141753(Traditional) ATTN: ZOYA LEE PHONE NO : 972 467 55122 DEGANIA BET SE DECISION MADE: 16-OCT-14 EMEK HAYARDEN IL 15130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T:SLIM INSULIN DELIVERY SYSTEM TANDEM DIABETES CARE, INC. 510(k) NO: K141758(Traditional) ATTN: JANICE HOGAN PHONE NO : 267 675-4600 1835 MARKET STREET, 29TH FLOOR SE DECISION MADE: 31-OCT-14 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS OAK RIDGE PRODUCTS, LLC 510(k) NO: K141759(Third Party – Traditional) ATTN: CONOR J O’MALLEY PHONE NO : 888 650-7444 4612 Century Ct SE DECISION MADE: 24-OCT-14 McHenry IL 60050 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: FDR D-EVO FLAT PANEL DETECTOR SYSTEM FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K141765(Traditional) ATTN: KATHERINE Y CHOI PHONE NO : 203 602-3568 419 WEST AVENUE SE DECISION MADE: 03-OCT-14 STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES ETHICON, INC. 510(k) NO: K141776(Traditional) ATTN: PETER CECCHINI PHONE NO : 908 218-2457 ROUTE 22 WEST SE DECISION MADE: 15-OCT-14 SOMERVILLE NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMET FUSION SYSTEM BIOMET SPINE 510(k) NO: K141791(Traditional) ATTN: TED KUHN PHONE NO : 303 501-8549 310 INTERLOCKEN PARKWAY SE DECISION MADE: 09-OCT-14 BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM COVIDIEN, LLC 510(k) NO: K141801(Traditional) ATTN: JULIE UNDERDAHL PHONE NO : 763 398-7000 3033 CAMPUS DRIVE SE DECISION MADE: 16-OCT-14 PLYMOUTH MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM DEFIBTECH, LLC 510(k) NO: K141809(Traditional) ATTN: Ed Horton PHONE NO : 203 453-6654 741 BOSTON POST ROAD SE DECISION MADE: 27-OCT-14 GUILFORD CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOPORE Polyganics BV 510(k) NO: K141816(Traditional) ATTN: BETTY IJMKER PHONE NO : 31 50 5886588 ROZENBURGLAAN 15A SE DECISION MADE: 23-OCT-14 GRONINGEN NL 9727DL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JAGWIRE HIGH PERFORMANCE GUIDWIRE BOSTON SCIENTIFIC CORP. 510(k) NO: K141820(Traditional) ATTN: ALLISON BAILLIE PHONE NO : 508 683-4942 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 21-OCT-14 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STARBAND, STARLIGHT ORTHOMERICA PRODUCTS, INC. 510(k) NO: K141842(Traditional) ATTN: DAVID C KERR PHONE NO : 407 290-6592 6333 N Orange Blossom Trl SE DECISION MADE: 06-OCT-14 ORLANDO FL 32810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOSPINE PEDICLE SCREW SYSTEM FLOSPINE 510(k) NO: K141850(Traditional) ATTN: RICH JANSEN PHONE NO : 612 281-5505 11821 BRAMBLE COVE DRIVE SE DECISION MADE: 27-OCT-14 FT. MYERS FL 33905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAYSTATION RAYSEARCH LABORATORIES AB 510(k) NO: K141860(Traditional) ATTN: DAVID HEDFORS PHONE NO : 46 722 366110 SVEAV 25, PLAN 9 SE DECISION MADE: 23-OCT-14 STOCKHOLM SE 111 34 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DANA ANTHROTRONIX, INC 510(k) NO: K141865(Traditional) ATTN: CORINA E LATHAN, PHD, PE PHONE NO : 240 498-9471 8737 COLESVILLE ROAD SUITE L-203 SE DECISION MADE: 15-OCT-14 SILVER SPRING MD 20910 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT HEMEDEX INCORPORATED 510(k) NO: K141869(Traditional) ATTN: DEAN HONKONEN PHONE NO : 617 577-1759 222 3rd St Suite 0123 SE DECISION MADE: 10-OCT-14 CAMBRIDGE MA 02142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPIDRESULTS RAMSOFT, INC. 510(k) NO: K141881(Traditional) ATTN: LELY LAM-HONG PHONE NO : 416 674134 7 EXT 213 243 COLLEGE ST.,SUITE 100 SE DECISION MADE: 31-OCT-14 TORONTO, ON CA M5T 1R5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHARKCORE FINE NEEDLE BIOPSY SYSTEM COVIDIEN LLC (FORMERLY BEACON ENDO510(k) NO: K141894(Traditional) ATTN: Saket Bhatt PHONE NO : 408 328-7357 2000 COMMONWEALTH AVE. SUITE 110 SE DECISION MADE: 06-OCT-14 AUBURNDALE MA 02466-2008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIORA V-TOUCH VIORA LTD. 510(k) NO: K141904(Traditional) ATTN: YORAM LEVY PHONE NO : 972 463 88837 31 HAAVODA ST. SE DECISION MADE: 21-OCT-14 BINYAMINA IL 30500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUAL SWITCH LASER ENGINEERING, INC. 510(k) NO: K141908(Special) ATTN: LAURIE DOBBS PHONE NO : 615 739-5418 475 METROPLEX DR. SUITE 401 SE DECISION MADE: 22-OCT-14 NASHVILLE TN 37211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K141912(Traditional) ATTN: ANNA HWANG PHONE NO : 310 533-9966 3203 KASHIWA STREET SE DECISION MADE: 29-OCT-14 TORRANCE CA 90505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR UNICON OPTICAL CO., LTD. 510(k) NO: K141917(Traditional) ATTN: MICHAEL LEE PHONE NO : 886 228 096995 NO. 45, MINGSHENG RD., DANSHUI DISSE DECISION MADE: 17-OCT-14 NEW TAIPEI TW 251 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYRA PARAINFLUENZA VIRUS ASSAY QUIDEL CORPORATION 510(k) NO: K141927(Traditional) ATTN: Ronald H Lollar PHONE NO : 740 589-3373 2005 E State St Suite 100 SE DECISION MADE: 09-OCT-14 ATHENS OH 45701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYRA ADENOVIRUS ASSAY QUIDEL CORPORATION 510(k) NO: K141931(Traditional) ATTN: Ronald H Lollar PHONE NO : 750 589-3373 2005 E State St Suite 100 SE DECISION MADE: 09-OCT-14 ATHENS OH 45701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES D STRYKER CORPORATE 510(k) NO: K141941(Traditional) ATTN: LILIAN ECKERT PHONE NO : 497 614 512117 BOETZINGER STR.41 SE DECISION MADE: 31-OCT-14 FREIBURG, BADEN-WUERTTEMBERG DE 7510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL TITAN SPINE, LLC 510(k) NO: K141953(Traditional) ATTN: CHRISTINE SCIFERT PHONE NO : 901 831-8053 3416 ROXEE RUN COVE SE DECISION MADE: 27-OCT-14 BARTLETT TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XCEL 455 SLIT LAMP REICHERT, INC. 510(k) NO: K141954(Special) ATTN: THOMAS M HECKMANN PHONE NO : 716 686-4500 3362 WALDEN AVE. SE DECISION MADE: 15-OCT-14 DEPEW NY 14043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY TOTAL JOINT ORTHOPEDICS, INC. 510(k) NO: K141972(Traditional) ATTN: CHRIS WEABER PHONE NO : 801 486-6070 1567 E. Stratford Avenue SE DECISION MADE: 09-OCT-14 Salt Lake City UT 84106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIODE LASER HAIR REMOVAL SYSTEM BEIJING ANCHORFREE TECHNOLOGY CO.,510(k) NO: K141973(Traditional) ATTN: Diana Hong PHONE NO : 86 21 22815850 P.O.BOX 237-023 SE DECISION MADE: 06-OCT-14 SHANGHAI CN 200030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FDR D-EVO II FLAT PANEL DETECTOR SYSTEM FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K142003(Traditional) ATTN: KATHERINE Y CHOI PHONE NO : 203 602-3568 419 WEST AVE. SE DECISION MADE: 21-OCT-14 STAMFORD CT 06902-6300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFIA DISTAL ACCESS CATHETER MICROVENTION, INC. 510(k) NO: K142014(Special) ATTN: Naomi Gong PHONE NO : 714 247-8055 1311 VALENCIA AVE SE DECISION MADE: 10-OCT-14 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE SPINEFRONTIER, INC. 510(k) NO: K142026(Traditional) ATTN: MEREDITH MAY PHONE NO : 719 337-7579 4628 NORTHPARK DRIVE SE DECISION MADE: 20-OCT-14 COLORADO SPRINGS CO 80918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 888 WNLE POWERED WHEELCHAIR PIHSIANG MACHINERY MFG. CO., LTD. 510(k) NO: K142027(Third Party – Traditional) ATTN: DAVID LIN PHONE NO : 310 328-8866 102 21184 FIGUEROA ST. SE DECISION MADE: 07-OCT-14 CARSON CA 90745 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP) NANOSPERE,INC. 510(k) NO: K142033(Traditional) ATTN: NOAH LERMER PHONE NO : 847 400-9000 4088 COMMERCIAL AVE SE DECISION MADE: 10-OCT-14 NORTHBROOK IL 60062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTRA HOLOGIC, INC. 510(k) NO: K142037(Traditional) ATTN: CATHERINE WILLIAMS PHONE NO : 408 352-0201 2585 AUGUSTINE DR SE DECISION MADE: 10-OCT-14 SANTA CLARA CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERCHONIA SHL ERCHONIA CORPORATION 510(k) NO: K142042(Traditional) ATTN: Kevin Walls PHONE NO : 720 962-5412 33 Golden Eagle Lane SE DECISION MADE: 21-OCT-14 Littleton CO 80127 510(k) STATEMENT
DEVICE: NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM NUVASIVE, INCORPORATED 510(k) NO: K142050(Traditional) ATTN: MICHELLE CHEUNG PHONE NO : 858 909-3360 7475 LUSK BLVD. SE DECISION MADE: 29-OCT-14 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVERSAL CLAMP SPINAL FIXATION SYSTEM ZIMMER SPINE, INC. 510(k) NO: K142053(Traditional) ATTN: HOLLY SEPPANEN PHONE NO : 952 830-6240 7375 BUSH LAKE RD. SE DECISION MADE: 29-OCT-14 MINNEAPOLIS MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: #8C RENEGADE DENTAL HANDPIECE HANDPIECE CLUB, LLC 510(k) NO: K142063(Traditional) ATTN: TINA WU PHONE NO : 443 352-3909 62 FOREST STREET, SUITE 300 SE DECISION MADE: 28-OCT-14 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS RTI SURGICAL, INC. 510(k) NO: K142070(Traditional) ATTN: KRISTINA HALL PHONE NO : 386 418-8888 4511 11621 Research Cir SE DECISION MADE: 27-OCT-14 ALACHUA FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VELASII THERAPY LASER SYSTEM ASPEN LASER SYSTEMS, LLC 510(k) NO: K142078(Traditional) ATTN: A. BRAUN HENDERSON PHONE NO : 303 751-2055 970 SOUTH DAWSON WAY #14 SE DECISION MADE: 30-OCT-14 AURORA CO 80012 510(k) STATEMENT
DEVICE: STALIF CTI, STALIF C CENTINEL SPINE, INC. 510(k) NO: K142079(Traditional) ATTN: JUSTIN EGGLETON PHONE NO : 202 552-5800 1331 H STREET NW, 12TH FLOOR SE DECISION MADE: 24-OCT-14 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT ZIMMER DENTAL INC. 510(k) NO: K142082(Traditional) ATTN: CHRISTINA BOYDSON PHONE NO : 760 919-4110 1900 ASTON AVE. SE DECISION MADE: 28-OCT-14 CARLSBAD CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX NCONTACT SURGICAL, INC. 510(k) NO: K142084(Traditional) ATTN: JANE RICUPERO PHONE NO : 919 655-1355 1001AVIATION PARKWAY, SUITE 400 SE DECISION MADE: 28-OCT-14 MORRISVILLE NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES GRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K142088(Traditional) ATTN: PATRICK CHOW PHONE NO : 008 522 8516789 BLOCK 6 AND 7, ZHU KENG INDUSTRIALSE DECISION MADE: 31-OCT-14 GUANG DONG CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REBOSSIS ORTHOREBIRTH CO., LTD. 510(k) NO: K142090(Traditional) ATTN: KEVIN A.THOMAS PHONE NO : 858 792-1235 12264 El Camino Real, Suite 400 SE DECISION MADE: 29-OCT-14 San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARIETENE MACROPOROUS MESH SOFRADIM PRODUCTION 510(k) NO: K142091(Traditional) ATTN: JENNIFER BRENNAN PHONE NO : 203 492-5346 60 MIDDLETOWN AVENUE SE DECISION MADE: 17-OCT-14 NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM Renovis Surgical Technologies, Inc510(k) NO: K142095(Special) ATTN: Sharyn Orton PHONE NO : 401 330-8264 200 HOMER AVE. SE DECISION MADE: 15-OCT-14 ASHLAND MA 01721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-PIECE RESUSCITATOR MERCURY MEDICAL 510(k) NO: K142096(Traditional) ATTN: PAUL DRYDEN PHONE NO : 239 498-2155 24301 WOODSAGE DRIVE SE DECISION MADE: 17-OCT-14 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABACUS (TM) SPACER SYSTEM SPINE WAVE, INC. 510(k) NO: K142101(Traditional) ATTN: ROAIDA JOHNSON PHONE NO : 203 944-9494 3 ENTERPRISE DRIVE, SUITE 210 SE DECISION MADE: 23-OCT-14 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIA 4.5 SPINAL SYSTEM STRYKER CORPORATION 510(k) NO: K142114(Traditional) ATTN: GARRY T HAYECK, PH.D. PHONE NO : 201 760-8043 2 PEARL COURT SE DECISION MADE: 27-OCT-14 ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM Roche Diagnostics 510(k) NO: K142133(Traditional) ATTN: Sarah Baumann PHONE NO : 317 521-3952 9155 HAGUE RD. SE DECISION MADE: 24-OCT-14 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISO-GARD MASK Teleflex Medical, Inc. 510(k) NO: K142138(Traditional) ATTN: BRIAN GALL PHONE NO : 919 544-8000 2917 WECK DR. SE DECISION MADE: 30-OCT-14 RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIS MODULIFT VBR SYSTEM AESCULAP IMPLANT SYSTEM, INC. 510(k) NO: K142150(Traditional) ATTN: LISA M BOYLE PHONE NO : 610 984-9274 3773 Corporate Parkway SE DECISION MADE: 29-OCT-14 Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM GE HEALTHCARE 510(k) NO: K142160(Traditional) ATTN: BRYAN BEHN PHONE NO : 414 721-4214 9900 INNOVATION DR. SE DECISION MADE: 10-OCT-14 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM – TIGECYCLINE (0.313-4UG/ML) GP Becton, Dickinson and Company 510(k) NO: K142170(Traditional) ATTN: MONICA E GIGUERE PHONE NO : 410 316-4287 7 Loveton Cir., MC 694 SE DECISION MADE: 28-OCT-14 Sparks MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DX-D IMAGING PACKAGE AGFA HEALTHCARE N.V. 510(k) NO: K142184(Traditional) ATTN: SHAEANN CAVANAGH PHONE NO : 864 421-1766 10 SOUTH ACADEMY ST. SE DECISION MADE: 16-OCT-14 GREENVILLE SC 29601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COGENT MED-LIF XL COGENT SPINE LLC 510(k) NO: K142193(Special) ATTN: JUDE PAGANELLI PHONE NO : 858 774 7891 101 N. ACACIA AVE SUITE 106 SE DECISION MADE: 15-OCT-14 SOLANA BEACH CA 92075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BNX Fine Needle Aspiration System Covidien LLC 510(k) NO: K142198(Traditional) ATTN: Saket Bhatt PHONE NO : 1 408 3287357 2000 Commonwealth Ave Suite 110 SE DECISION MADE: 08-OCT-14 Auburndale MA 02466 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ascendra Balloon Aortic Valvaloplasty Catheter EDWARDS LIFESCIENCES 510(k) NO: K142199(Traditional) ATTN: Susan Reynolds PHONE NO : 949 7564518 ONE EDWARDS WAY SE DECISION MADE: 29-OCT-14 IRVINE CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) NOVA BIOMEDICAL CORPORATION 510(k) NO: K142220(Traditional) ATTN: Paul W. MacDonald PHONE NO : 781 8940800 200 PROSPECT ST. SE DECISION MADE: 17-OCT-14 WALTHAM MA 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EpiAccess System EpieP, Inc. 510(k) NO: K142245(Traditional) ATTN: Pamela Bunes PHONE NO : 864 4232526 142 Temple Street, Suite 206 SE DECISION MADE: 29-OCT-14 New Haven CT 06510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XprESS Multi-Sinus Dilation Tool ENTELLUS MEDICAL, INC. 510(k) NO: K142252(Special) ATTN: Karen E. Peterson PHONE NO : 763 4637066 3600 Holly Lane North, Suite 40 SE DECISION MADE: 17-OCT-14 Plymouth MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sherlock 3CG Tip Positioning System Stylet C.R.Bard, Inc. 510(k) NO: K142267(Traditional) ATTN: Bryan Stone PHONE NO : 1 801 5225876 605 North 5600 West SE DECISION MADE: 17-OCT-14 Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Varian Verification System (VVS) VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K142268(Traditional) ATTN: Peter J. Coronado PHONE NO : 650 4246320 3100 HANSEN WAY SE DECISION MADE: 02-OCT-14 PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens NEO VISION CO., LTD. 510(k) NO: K142275(Traditional) ATTN: Kyung Hwa Kim PHONE NO : 82 31 8892040 1029 YEONGDOEK-DONG, GIHENUNG-GU YSE DECISION MADE: 07-OCT-14 GYEONGGI-DO KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JULIET PO SPINEART 510(k) NO: K142277(Traditional) ATTN: Franck Pennesi PHONE NO : 41 22 5701246 INTERNATIONAL CENTER COINTRIN 20 RSE DECISION MADE: 14-OCT-14 GENEVA CH 1215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) HEALGEN SCIENTIFIC LLC 510(k) NO: K142280(Traditional) ATTN: Jianqiu Fang PHONE NO : 1 713 7338088 5213 MAPLE STREET SE DECISION MADE: 16-OCT-14 BELLAIRE TX 77401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM ZIMMER, INC. 510(k) NO: K142281(Traditional) ATTN: PATRICK MCCULLAGH PHONE NO : 574 272 4656 P.O. BOX 708 SE DECISION MADE: 22-OCT-14 WARSAW IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NS3000 Holmium Laser System New Star Lasers, Inc. 510(k) NO: K142286(Special) ATTN: Natalie Vollrath PHONE NO : 1 916 6771900 9085 Foothills Blvd. SE DECISION MADE: 31-OCT-14 Roseville CA 95747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System Polymer Technology Systems, Inc. 510(k) NO: K142302(Traditional) ATTN: Jack Rogers PHONE NO : 1 317 8705610 1064 7736 Zionsville Rd. SE DECISION MADE: 02-OCT-14 Indianapolis IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Viberect Penile Vibratory Stimulation Device REFLEXONIC, LLC 510(k) NO: K142304(Traditional) ATTN: Kambiz Tajkarimi PHONE NO : 301 3788433 915 Toll House Avenue, Suite 205 SE DECISION MADE: 03-OCT-14 Frederick MD 21701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System GE MEDICAL SYSTEMS ISRAEL LTD. 510(k) NO: K142323(Traditional) ATTN: Bryan Behn PHONE NO : 972 4 8519619 4 Etgar Street SE DECISION MADE: 10-OCT-14 Tirat Carmel IL 39120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Urine/CSF Albumin, Urine/CSF Albumin Calibrator Beckman Coulter Ireland Inc. 510(k) NO: K142346(Traditional) ATTN: Anne-Marie Shine PHONE NO : 353 65 6831138 Lismeehan, O’Callaghan’s Mills SE DECISION MADE: 15-OCT-14 Co. Clare IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test W.H.P.M., Inc. 510(k) NO: K142353(Traditional) ATTN: John Wan PHONE NO : 1 626 4438480 5358 Irwindale Ave SE DECISION MADE: 07-OCT-14 Irwindale CA 91706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vasc Band hemostat Lepu Medical Technology (Beijing) 510(k) NO: K142359(Traditional) ATTN: Kim Xiangdan PHONE NO : No. 37 Chaoqian Road SE DECISION MADE: 23-OCT-14 Beijing CN 102200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Barrx RFA Self Sizing Balloon Catheter Covidien llc 510(k) NO: K142364(Special) ATTN: Rachel Silva PHONE NO : 1 408 3287359 15 Hampshire Street SE DECISION MADE: 01-OCT-14 Mansfield MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pico Way Laser System CANDELA CORPATION 510(k) NO: K142372(Traditional) ATTN: Ruthie Amir PHONE NO : 508 3587400 330 530 BOSTON POST ROAD SE DECISION MADE: 30-OCT-14 WAYLAND MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xia 3 Spinal System STRYKER CORP. 510(k) NO: K142381(Traditional) ATTN: GARRY T HAYECK PHONE NO : 201 7608043 2 PEARL COURT SE DECISION MADE: 21-OCT-14 ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests Chemtron Biotech, Inc. 510(k) NO: K142396(Traditional) ATTN: Jane Zhang PHONE NO : 858 4500044 9245 Brown Deer Road SE DECISION MADE: 09-OCT-14 San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Miltex N-Tralig Intraligamentary Syringe INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K142414(Special) ATTN: Judith E. O’Grady PHONE NO : 609 2750500 311 ENTERPRISE DR. SE DECISION MADE: 30-OCT-14 PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Uroflowmeter BE TECHNOLOGIES, INC. 510(k) NO: K142425(Traditional) ATTN: Edward Belotserkovsky PHONE NO : 415 3078531 2939 20th Avenue SE DECISION MADE: 27-OCT-14 San Francisco CA 94132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cryoICE croablation probe ATRICURE, INC. 510(k) NO: K142441(Special) ATTN: Jonathan McElwee PHONE NO : 513 6444249 6217 CENTER PARK DRIVE SE DECISION MADE: 29-OCT-14 WEST CHESTER OH 45069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM ZIMMER, INC. 510(k) NO: K142442(Traditional) ATTN: PATRICK MCCULLAGH PHONE NO : 574 3724656 P.O. BOX 708 SE DECISION MADE: 03-OCT-14 WARSAW IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Site-Rite 6 Ultrasound System with Pinpoint GT Technology C.R. Bard, Inc 510(k) NO: K142443(Traditional) ATTN: Kerrie Hamblin PHONE NO : 801 5224909 605 North 5600 West SE DECISION MADE: 30-OCT-14 Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIVERGENCE Anterior Cervical Fusion System MEDTRONIC SOFAMOR DANEK USA, INC 510(k) NO: K142450(Special) ATTN: Shweta Sharma PHONE NO : 901 3963133 1800 PYRAMID PLACE SE DECISION MADE: 01-OCT-14 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPEDIUM Spine System/Synapse System JOHNSON AND JOHNSON 510(k) NO: K142460(Special) ATTN: Jaclyn Porsolt PHONE NO : 1 508 8283269 325 PARAMOUNT DR. SE DECISION MADE: 01-OCT-14 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UGEO PT60A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD 510(k) NO: K142466(Third Party – Traditional) ATTN: PARK KYEONG-MI PHONE NO : 822 2194 1373 42, TEHERAN-RO 108-GIL, SE DECISION MADE: 03-OCT-14 GANGNAM-GU KR 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: Sternal Closure System JACE Medical LLC 510(k) NO: K142484(Traditional) ATTN: Justin May PHONE NO : 574 5271663 536 East 200 North SE DECISION MADE: 31-OCT-14 Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra Siemens Medical Solutions USA, Inc510(k) NO: K142515(Special) ATTN: Cordell L. Fields PHONE NO : 1 610 2198518 51 Valley Stream Parkway, MailcodeSE DECISION MADE: 08-OCT-14 Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SolfVue DELPHINUS MEDICAL TECHNOLOGIES, IN510(k) NO: K142517(Traditional) ATTN: Andrea N Wallen-Gerding PHONE NO : 1 734 2333088 46701 COMMERCE CENTER DRIVE SE DECISION MADE: 31-OCT-14 PLYMOUTH MI 48170 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HyProCure II Graham Medical Technologies, L.L.C510(k) NO: K142534(Traditional) ATTN: ANGELA RECCHIA PHONE NO : 586 6779600 16137 LEONE DRIVE SE DECISION MADE: 03-OCT-14 MACOMB MI 48042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220) JVC KENWOOD CORPORATION 510(k) NO: K142536(Traditional) ATTN: TSUKASA TASHIRO PHONE NO : 81 258 246611 3-12, MORIYACHO, KANAGAWA-KU SE DECISION MADE: 03-OCT-14 YOKOHAMA-SHI JP 221-0022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LiNA SafeAir Smoke Pencil LINA MEDICAL APS 510(k) NO: K142538(Special) ATTN: Louisa Memborg PHONE NO : 454 329 6652 FORMERVAGEN 5 SE DECISION MADE: 06-OCT-14 GLOSTRUP DK 2600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244) JVC KENWOOD CORPORATION 510(k) NO: K142540(Traditional) ATTN: Tsukasa Tashiro PHONE NO : 81 258 246611 3-12, MORIYA-CHO, KANAGAWA-KU SE DECISION MADE: 03-OCT-14 YOKOHAMA-SHI JP 221-0022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexible Video-Uretero-Choledochoscope System KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K142556(Traditional) ATTN: Mike Samuels PHONE NO : 424 2188288 2151 E. GRAND AVENUE SE DECISION MADE: 23-OCT-14 EL SEGUNDO CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Well Lead PVC Urethral Catheter WELL LEAD MEDICAL CO., LTD. 510(k) NO: K142563(Traditional) ATTN: Han Guang Yuan PHONE NO : 86 20 84758878 C-4#Jinhu Industrial Estate, HualoSE DECISION MADE: 28-OCT-14 Guangzhou CN 511434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K142574(Special) ATTN: TRACEY HANNON PHONE NO : 508 8808033 325 PARAMOUNT DR. SE DECISION MADE: 24-OCT-14 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bard RiteCath Intermittent Urinary Catheter C.R. Bard, Inc. 510(k) NO: K142575(Traditional) ATTN: Michele Davis PHONE NO : 770 7846274 8195 Industrial Blvd SE DECISION MADE: 31-OCT-14 Covington GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zimmer Periarticular Plating System ZIMMER, INC. 510(k) NO: K142579(Traditional) ATTN: Patrick McCullagh PHONE NO : 574 3724656 P.O. BOX 708 SE DECISION MADE: 22-OCT-14 WARSAW IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL TITAN SPINE, LLC 510(k) NO: K142589(Special) ATTN: Jane Rodd PHONE NO : 262 2427801 6140 WEST EXECUTIVE DRIVE, SUITE ASE DECISION MADE: 17-OCT-14 MEQUON WI 53092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALOR Hindfoot Fusion Nail System WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K142602(Special) ATTN: VAL MYLES PHONE NO : 1 901 2905162 1023 CHERRY ROAD SE DECISION MADE: 22-OCT-14 MEMPHIS TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker Precision HD Camera System Stryker Endoscopy 510(k) NO: K142603(Third Party – Traditional) ATTN: Angela Wong PHONE NO : 1 408 7542000 5900 Optical Court SE DECISION MADE: 23-OCT-14 San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: AngioDynamics VenaCure EVLT Tre? Sheath and VenaCure EVLT NeverTouch Procedure Kits AngioDynamics, Inc. 510(k) NO: K142614(Special) ATTN: Teri Juckett PHONE NO : 518 7951142 603 Queensbury Avenue SE DECISION MADE: 10-OCT-14 Queensbury NY 12804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICC Maximal Barrier Nursing Kit NAVILYST MEDICAL, INC. 510(k) NO: K142616(Special) ATTN: WANDA CARPINELLLA PHONE NO : 508 6587929 26 FOREST STREET SE DECISION MADE: 14-OCT-14 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System Hitachi Aloka Medical America, Inc510(k) NO: K142618(Special) ATTN: Angela Van Arsdale PHONE NO : 203 2695088 10 Fairfield Blvd SE DECISION MADE: 16-OCT-14 Wallingford CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acuson SC2000 Diagnostic Ultrasound System SIEMENS MEDICAL SOLUTIONS, INC. 510(k) NO: K142628(Third Party – Traditional) ATTN: Kevin Kong PHONE NO : 650 9699112 685 EAST MIDDLEFIELD RD. SE DECISION MADE: 10-OCT-14 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: Merit 10mL Syringe Merit Medical Systems, Inc. 510(k) NO: K142636(Special) ATTN: Mridi Kumathe PHONE NO : 1 801 2084712 1600 W Merit Parkway SE DECISION MADE: 17-OCT-14 South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-Lok and G-Lok XL Extender T.A.G. Medical Products Corporatio510(k) NO: K142653(Special) ATTN: Tomer Alon PHONE NO : 972 4 9858400 D.N. Ashrat SE DECISION MADE: 16-OCT-14 Kibbutz Gaaton IL 25130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fortex 0.035 OTW PTA Balloon Catheter Covidien LLC 510(k) NO: K142654(Third Party – Traditional) ATTN: Rupali Gupta PHONE NO : 1 763 3987000 3033 Campus Drive SE DECISION MADE: 28-OCT-14 Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: Antegrade LeMills Valvulotome LeMaitre Vascular, Inc. 510(k) NO: K142660(Special) ATTN: Xiang (Vic) Zhang PHONE NO : 781 2212266 102 63 Second Avenue SE DECISION MADE: 17-OCT-14 Burlington MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vericore Zirconia Blanks WHIP MIX CORPORATION 510(k) NO: K142670(Special) ATTN: JOHN WATERS PHONE NO : 502 6371451 361 FARMINGTON AVE SE DECISION MADE: 22-OCT-14 LOUISVILLE KY 40217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PerkinElmer, XRpad 4343 F MED Flat Panel Detector PerkinElmer, Inc 510(k) NO: K142698(Special) ATTN: Dawn Spooner PHONE NO : 781 6636071 940 Winter Street SE DECISION MADE: 23-OCT-14 Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERADIUS UNITY PHILIPS MEDICAL SYSTEMS NETHRLANDS510(k) NO: K142708(Abbreviated) ATTN: Jeanette Becker PHONE NO : 31 06113 86380 VEENPLUIS 4-6 SE DECISION MADE: 22-OCT-14 BEST NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CrossCLIP Implant System OrthoDiscovery Group LLC(D.B.A. Cr510(k) NO: K142727(Traditional) ATTN: Vernon Hartdegen PHONE NO : 1 901 2218406 458 DISTRIBUTION PKWY SE DECISION MADE: 24-OCT-14 COLLIERVILLE TN 38017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-CUBE 5 ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K142733(Traditional) ATTN: DONGHWAN KIM PHONE NO : 82 70 74652068 1, 6 AND 7FL, VERDI TOWER 72, DIGISE DECISION MADE: 28-OCT-14 SEOUL KR 152-848 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Siemens 3.0 Blanket Array Coil RESONANCE INNOVATIONS LLC 510(k) NO: K142755(Traditional) ATTN: Randall Jones PHONE NO : 1 402 9342650 9840 S. 140TH ST., STE 8 SE DECISION MADE: 23-OCT-14 OMAHA NE 68138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LiNA PowerBlade Plus HC LiNA Medical ApS 510(k) NO: K142757(Special) ATTN: Louisa Memborg PHONE NO : 454 3296652 Formervangen 5 SE DECISION MADE: 23-OCT-14 Glostrup DK 2600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface Medtronic, Inc 510(k) NO: K142784(Special) ATTN: Lisa Stone PHONE NO : 1 763 5149866 8200 Coral Sea Street NE SE DECISION MADE: 24-OCT-14 Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM) Siemens Healthcare Diagnostics Inc510(k) NO: K142811(Traditional) ATTN: Asha Gartland PHONE NO : 914 5243257 511 Benedict Avenue SE DECISION MADE: 29-OCT-14 Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON Spinal System MEDTRONIC SOFAMOR DANCK USA, INC. 510(k) NO: K142847(Traditional) ATTN: LAVEEDA LEFLORE PHONE NO : 1 901 3463133 1800 PYRAMID PLACE SE DECISION MADE: 27-OCT-14 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens Unilens Corp., USA 510(k) NO: K142851(Special) ATTN: Alan J. Frazer PHONE NO : 727 5442531 10431 72nd Street North SE DECISION MADE: 30-OCT-14 Largo FL 33777 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM) SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K142864(Traditional) ATTN: Fatima Pacheco PHONE NO : 1 914 5242450 511 BENEDICT AVENUE SE DECISION MADE: 29-OCT-14 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Premium Surgiclip III COVIDIEN 510(k) NO: K142869(Special) ATTN: Michael Koczocik PHONE NO : 1 203 4926312 60 Middletown Avenue SE DECISION MADE: 30-OCT-14 North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K142876(Third Party – Traditional) ATTN: NANCY BURKE PHONE NO : 1 425 2958665 685 East Middlefield Road SE DECISION MADE: 23-OCT-14 Mountain CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K142878(Abbreviated) ATTN: Donna Velasquez PHONE NO : 1 310 6458200 7403 5210 Pacific Concourse Drive SE DECISION MADE: 30-OCT-14 Los Angeles CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-CUBE 12 ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K142884(Traditional) ATTN: Donghwan Kim PHONE NO : 82 70 74652068 1, 6 AND 7FL, VERDI TOWER 72, DIGISE DECISION MADE: 28-OCT-14 SEOUL KR 152-848 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh SOFRADIM PRODUCTION 510(k) NO: K142900(Special) ATTN: Eric Jague PHONE NO : 33 4 74089000 116 AVENUE DU FORMANS SE DECISION MADE: 28-OCT-14 TREVOUX FR 01600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leo Minor SUNNEX, INC. 510(k) NO: K142984(Third Party – Traditional) ATTN: TISH MENDICK PHONE NO : 402 8509485 9319 FORSYTH PARK DRIVE SE DECISION MADE: 29-OCT-14 CHARLOTTE NC 28273 510(k) STATEMENT THIRD PARTY REVIEW
Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance
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