October 2014 510(k) Clearances
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