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U.S. Department of Health and Human Services

Medical Devices

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July 2012 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD July 2012


DEVICE: K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER
CURATIVE MEDICAL INC.             510(k) NO: K120285(TRADITIONAL)
ATTN: AMY  MCKINNEY               PHONE NO : 979 236 1622   
63 CHICORY CT                     SE DECISION MADE: 02-JUL-12
LAKE JACKSON TX 77566             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
ALFA WASSERMANN                   510(k) NO: K113435(TRADITIONAL)
ATTN: HYMAN  KATZ                 PHONE NO : 973 852 0158   
4 Henderson Drive                 SE DECISION MADE: 02-JUL-12
Caldwell NJ 07006                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY
ELEKTA INC. D/B/A NUCLETRON CORPOR510(k) NO: K121448(TRADITIONAL)
ATTN: THOMAS  VALENTINE           PHONE NO : 770 670 2548   
7 ST. PAUL ST, STE 1660           SE DECISION MADE: 02-JUL-12
BALTIMORE MD 21202                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASTHMAPOLIS SYSTEM
RECIPROCAL LABS CORPORATION       510(k) NO: K121609(TRADITIONAL)
ATTN: INGER L COUTURE             PHONE NO : 608 251 0470   
612 W. MAIN STREET STE. 201       SE DECISION MADE: 02-JUL-12
MADISON WI 53703                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TRINON Q & Q3 IMPLANT SYSTEM
TRINON TITANIUM GMBH              510(k) NO: K103577(TRADITIONAL)
ATTN: MARKUS  DENK                PHONE NO : 497 462 924051
SCHWARZWALDSTRASSE 5              SE DECISION MADE: 03-JUL-12
TUTTLINGEN    GM 78576            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP
INOTEC AMD LTD.                   510(k) NO: K112634(TRADITIONAL)
ATTN: DIANE  HORWITZ              PHONE NO : 703 307 2921   
2995 STEVEN MARTIN DR.            SE DECISION MADE: 03-JUL-12
FAIRFAX VA 22031                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINAL ELEMENTS CERCLAGE SYSTEM
SPINAL ELEMENTS, INC.             510(k) NO: K120177(TRADITIONAL)
ATTN: BENJAMIN A KIMBALL          PHONE NO : 760 607 1816   
2744 LOKER AVE. W. SUITE 100      SE DECISION MADE: 03-JUL-12
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORANGE COLORED CONDOMS ORANGE SCENT
KAREX INDUSTRIES SDN BHD          510(k) NO: K113056(SPECIAL)
ATTN: LAI PENG  LIM               PHONE NO : 607 687 8833
PTD. 7906/7907, TAMAN PONTIAN JAYASE DECISION MADE: 03-JUL-12
PONTIAN, JOHOR    MY 82000        510(k) STATEMENT

DEVICE: ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT
ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K113262(TRADITIONAL)
ATTN: HYMAN  KATZ                 PHONE NO : 973 852 0158   
4 HENDERSON DRIVE                 SE DECISION MADE: 03-JUL-12
WEST CALDWELL NJ 07006            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K120634(SPECIAL)
ATTN: PINJUNG  CHEN               PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD WUGU DISE DECISION MADE: 03-JUL-12
NEW TAIPEI CITY    TW 24888       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINE FRONTIER INDUS ACP SYSTEM
SPINEFRONTIER, INC.               510(k) NO: K121060(SPECIAL)
ATTN: FREDY H VARELA              PHONE NO : 978 232 3990   
500 CUMMINGS CENTER SUITE 3500    SE DECISION MADE: 03-JUL-12
BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM
CONSTANT CARE, LLC                510(k) NO: K120941(TRADITIONAL)
ATTN: SETH A MAILHOT              PHONE NO : 202 469 4980   
1300 I ST, NW, 11TH FLOOR EAST    SE DECISION MADE: 03-JUL-12
WASHINGTON DC 20005 3314          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)
GLOBUS MEDICAL, INC.              510(k) NO: K121107(SPECIAL)
ATTN: SARAH M FITZGERALD          PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 03-JUL-12
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
CINCINNATI SUB-ZERO PRODUCTS, INC.510(k) NO: K121669(SPECIAL)
ATTN: STEVEN J BERKE              PHONE NO : 513 772 8810   
12011 MOSTELLER RD.               SE DECISION MADE: 03-JUL-12
CINCINNATI OH 45241               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
AIRSTRIP TECHNOLOGIES, LP         510(k) NO: K121871(TRADITIONAL)
ATTN: ROBERT ANDREW  MILLER       PHONE NO : 
335 E. SONTERRA BLVD. SUITE 200   SE DECISION MADE: 03-JUL-12
SAN ANTONIO TX 78258              510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR
WILLIAM COOK EUROPE APS           510(k) NO: K121629(TRADITIONAL)
ATTN: JENNIFER  BROWN             PHONE NO : 765 463 7537   
1 GEDDES WAY                      SE DECISION MADE: 03-JUL-12
WEST LAFAYETTE IN 47906           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
SURGIQUEST, INC.                  510(k) NO: K121336(SPECIAL)
ATTN: DANIEL  DONOVAN             PHONE NO : 203 799 2400   
333 Quarry Rd                     SE DECISION MADE: 03-JUL-12
Milford CT 06460                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL
BIOCHEMICAL DIAGNOSTIC, INC.      510(k) NO: K121122(TRADITIONAL)
ATTN: ALLEN  PANETZ               PHONE NO : 631 595 9200   
180 HEARTLAND BLVD.               SE DECISION MADE: 03-JUL-12
Edgewood NY 11717                 510(k) STATEMENT

DEVICE: UTB BLUE POWDER FREE NITRILE
NORTHSTAR HEALTHCARE HOLDINGS     510(k) NO: K121506(TRADITIONAL)
ATTN: WESLEY  TOAVS               PHONE NO : 441 278 3827
HAMILTON HOUSE, 10 QUEEN ST       SE DECISION MADE: 03-JUL-12
HAMILTON, BERMUDA    EI HM11      510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DEPUY PULSE LUMBAR CAGE SYSTEM
MEDOS INTERNATIONAL SARL          510(k) NO: K120966(TRADITIONAL)
ATTN: ROBIN  DINARDO              PHONE NO : 508 977 3966   
325 PARAMOUNT DRIVE               SE DECISION MADE: 03-JUL-12
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERICAM PSI
PERIMED AB                        510(k) NO: K120884(TRADITIONAL)
ATTN: MARIA  LILJEVRET            PHONE NO : 468 580 11990
DATAVAGEN 9 A                     SE DECISION MADE: 03-JUL-12
JARFALLA    SE 17543              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA
ASTRA TECH INC.                   510(k) NO: K120338(TRADITIONAL)
ATTN: B A BROWN                   PHONE NO : 847 560 4406   
8944 TAMAROA TERRACE              SE DECISION MADE: 05-JUL-12
SKOKIE IL 60076                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ILUMINAGE DIODE LASER
CYNOSURE, INC.                    510(k) NO: K111454(TRADITIONAL)
ATTN: GEORGE  CHO                 PHONE NO : 978 256 4200   
5 CARLISLE ROAD                   SE DECISION MADE: 05-JUL-12
WESTFORD MA 01886                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOPURE PORTABLE RO SYSTEMS
ARION WATER, INC.                 510(k) NO: K112331(TRADITIONAL)
ATTN: ROBERT  LIVINGSTION         PHONE NO : 508 465 2280   
1 COMMERCE WAY BLDG 1 UNIT C      SE DECISION MADE: 05-JUL-12
CARVER MA 02330                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR
NEXERA MEDICAL INC                510(k) NO: K120244(TRADITIONAL)
ATTN: PAUL  SALLARULO             PHONE NO : 954 495 2020   
3343 W Commercial Blvd Ste 103    SE DECISION MADE: 05-JUL-12
Fort Lauderdale FL 33309          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD MAX MRSA ASSAY, BD MAX INSTRUMENT
BD DIAGNOSTICS (GENEOHM SCIENCES C510(k) NO: K120138(TRADITIONAL)
ATTN: RAYMOND J BOULE             PHONE NO : 410 316 4542   
7 LOVETON CIRCLE, MAIL CODE 614   SE DECISION MADE: 05-JUL-12
SPARKS MD 21152                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCULIF TL CAGE
COALIGN INNOVATIONS, INC.         510(k) NO: K121683(SPECIAL)
ATTN: JUSTIN  EGGLETON            PHONE NO : 202 552 5800   
1331 H STREET NW 12TH FLOOR       SE DECISION MADE: 05-JUL-12
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K121680(SPECIAL)
ATTN: CHRIS  MCKEE                PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 05-JUL-12
Memphis TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNAPSE 3D CARDIAC TOOLS
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K120636(TRADITIONAL)
ATTN: JYH-SHYAN  LIN              PHONE NO : 301 251 1092   
419 WEST AVE.                     SE DECISION MADE: 05-JUL-12
STAMFORD CT 06902                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM
TORNIER, INC.                     510(k) NO: K120739(TRADITIONAL)
ATTN: BRAHIM  HADRI               PHONE NO : 781 249 8030   
7701 FRANCE AVE SOUTH SUITE 600   SE DECISION MADE: 05-JUL-12
EDINA MN 55435                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIOPACS
LUMEDX                            510(k) NO: K120514(ABBREVIATED)
ATTN: CHRIS  PEARCE               PHONE NO : 425 818 2312   
110, 110TH AVE NE                 SE DECISION MADE: 05-JUL-12
BELLEVUE WA 98004                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S
DENTIN IMPLANTS TECHNOLOGIES LTD. 510(k) NO: K120530(TRADITIONAL)
ATTN: DANIELA  LEVY               PHONE NO : 213 447 5297   
22817 VENTURA BLVD. #161          SE DECISION MADE: 05-JUL-12
WOODLAND HILLS CA 91364           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIMPLANT GO
MATERIALISE DENTAL NV             510(k) NO: K120733(TRADITIONAL)
ATTN: GEERT  APPELTANS            PHONE NO : 32 16 396620
TECHNOLOGIELAAN 15                SE DECISION MADE: 05-JUL-12
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLUE POWER FREE NITRILE EXAMINATION GLOVE
CYPRESS MEDICAL PRODUCTS LLC      510(k) NO: K121464(TRADITIONAL)
ATTN: ALEX  NAGY                  PHONE NO : 815 385 0100   
1202 SOUTH ROUTE 31               SE DECISION MADE: 05-JUL-12
MCHENRY IL 60050                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR
COOK INCORPORATED                 510(k) NO: K120468(TRADITIONAL)
ATTN: SUSANNE  GALIN              PHONE NO : 812 339 2235   
750 DANIELS WAY                   SE DECISION MADE: 06-JUL-12
BLOOMINGTON IN 47404              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAVIS TORQUER
NAVIS MEDICAL,INC                 510(k) NO: K112674(TRADITIONAL)
ATTN: MATTHEW J HUDDLESTON        PHONE NO : 614 596 7204   
5705 WHISPERING TRL               SE DECISION MADE: 06-JUL-12
GALENA OH 43021                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMARTDRIVE WHEELCHAIR POWER-ASSIST
MAX MOBILITY, LLC                 510(k) NO: K113621(TRADITIONAL)
ATTN: WILLIAM M RICHTER           PHONE NO : 615 731 1860   
5425 MOUNT VIEW PARKWAY           SE DECISION MADE: 06-JUL-12
ANTIOCH TN 37013                  510(k) STATEMENT

DEVICE: SAFETY SUBCUTANEOUS TISSUE INFUSION SET
MULTI MED                         510(k) NO: K120195(TRADITIONAL)
ATTN: TANYA  O'BRIEN              PHONE NO : 813 645 2855   
962 ALLEGRO LANE                  SE DECISION MADE: 06-JUL-12
APOLLO BEACH FL 33572             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MECHANICAL WHEELCHAIR
NOVAF ANDALUCIA 2007, SL          510(k) NO: K120302(TRADITIONAL)
ATTN: FERNANDO  SAENZ DE SANTAMARIPHONE NO : 349 568 43675
CAMINO SE SANTA TERESA NAVE 1     SE DECISION MADE: 06-JUL-12
ROTA    SP PC 11520               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM
APEX BIO TECHNOLOGY CORP          510(k) NO: K120649(SPECIAL)
ATTN: LISA  LIU                   PHONE NO : 011 886 35641952
NO. 7, LI-HSIN ROAD V HSINCHU SCIESE DECISION MADE: 06-JUL-12
HSINCHU    TW 30078               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES MULTILOC HUMERAL NAILING SYSTEM
SYNTHES USA PRODUCTS LLC          510(k) NO: K120807(TRADITIONAL)
ATTN: REBECCA  BLANK              PHONE NO : 610 719 1268   
1301 GOSHEN PARKWAY               SE DECISION MADE: 06-JUL-12
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUNFLOWER WARNER
ATOM MEDICAL CORPORATION          510(k) NO: K120937(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 06-JUL-12
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE
SYNTHES USA                       510(k) NO: K121601(TRADITIONAL)
ATTN: ANGELA F LASSANDRO          PHONE NO : 610 719 6854   
1301 GOSHEN PKWY                  SE DECISION MADE: 06-JUL-12
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLIGHT 60 VENTILATOR
FLIGHT MEDICAL INNOVATIONS LTD.   510(k) NO: K120726(TRADITIONAL)
ATTN: CHOSHANA  FRIEDMAN          PHONE NO : 704 899 0092   
1914 JN PEASE PLACE               SE DECISION MADE: 06-JUL-12
CHARLOTTE NC 28262                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
FLEXIBLE STENTING SOLUTIONS, INC. 510(k) NO: K121125(TRADITIONAL)
ATTN: JOSEPH C GRIFFIN III        PHONE NO : 732 578 0060   
23 Christopher Way, Suite 103     SE DECISION MADE: 06-JUL-12
Eatontown NJ 07724                510(k) STATEMENT

DEVICE: VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
L & K BIOMED CO., LTD             510(k) NO: K121096(SPECIAL)
ATTN: KI HYANG  KIM               PHONE NO : 822 262 41471
ROOM 1104, ACE HIGH-END TOWER3 371SE DECISION MADE: 06-JUL-12
SEOUL    KS 153803                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE
SACKS HOLDINGS, INC.              510(k) NO: K121030(TRADITIONAL)
ATTN: DEVIN  CHODOROW             PHONE NO : 617 510 8796   
P.O. BOX 676211                   SE DECISION MADE: 06-JUL-12
RANCHO SANTA FE CA 92067          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEATLUX
HOME SKINOVATIONS LTD.            510(k) NO: K120582(TRADITIONAL)
ATTN: AMIR  WALDMAN, PH.D         PHONE NO : 972 547 404616
TAVOR BULD. POB 533               SE DECISION MADE: 06-JUL-12
YOKNEAM ILLIT    IS 20692         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET, THINKINGARCHIVE (OR NUPAX) - THE MANAGEMENT AND ARCHIV
THINKING SYSTEMS CORP.            510(k) NO: K120305(TRADITIONAL)
ATTN: JB  WANG                    PHONE NO : 727 217 0909   
750 94TH AVE., N. SUITE 211       SE DECISION MADE: 09-JUL-12
SAINT PETERSBURG FL 33702         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANA-SCREEN WITH MDSS
BIO-RAD LABORATORIES              510(k) NO: K113610(SPECIAL)
ATTN: JUANG  WANG                 PHONE NO : 510 741 4609   
BIOPLEX 2200 DIVISION 5500 EAST SESE DECISION MADE: 09-JUL-12
BENICIA CA 94510                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEVIIN REVERSE SHOULDER
INGEN ORTHOPEDICS LLC             510(k) NO: K120374(TRADITIONAL)
ATTN: PERRY  GEREMAKIS            PHONE NO : 609 409 3316   
2650 US HIGHWAY 130               SE DECISION MADE: 09-JUL-12
CRANBURY NJ 08512                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OXYBAND WOUND DRESSING
O2S, LLC                          510(k) NO: K121407(TRADITIONAL)
ATTN: DAVID E PETKO, P.E.         PHONE NO : 215 299 8742   
1500 SPRING GARDEN ST             SE DECISION MADE: 09-JUL-12
PHILADELPHIA PA 19130             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S-SCAN
ESAOTE, S.P.A.                    510(k) NO: K121650(SPECIAL)
ATTN: ALLISON  SCOTT              PHONE NO : 317 569 9500   
9001 WESLEYAN ROAD SUITE 200      SE DECISION MADE: 09-JUL-12
INDIANAPOLIS IN 46268             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM
COVIDIEN LLC                      510(k) NO: K120773(TRADITIONAL)
ATTN: CHARLIE  MACK               PHONE NO : 541 376 5063   
77325 JOYCE WAY                   SE DECISION MADE: 10-JUL-12
ECHO OR 97826 .                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
GENORAY CO., LTD.                 510(k) NO: K120263(TRADITIONAL)
ATTN: JAE  KIM                    PHONE NO : 714 289 8020   
1073 N. BATAVIA ST                SE DECISION MADE: 10-JUL-12
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY
GYRUS ACMI, INC.                  510(k) NO: K120474(TRADITIONAL)
ATTN: GRAHAM  BAILLE              PHONE NO : 508 804 2738   
136 TURNPIKE RD.                  SE DECISION MADE: 10-JUL-12
SOUTHBOROUGH MA 01772             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STATIM 2000 G4 CASSETTE
SCICAN LTD.                       510(k) NO: K112872(SPECIAL)
ATTN: TERESA  BOYCE               PHONE NO : 416 445 1600
1440 DON MILLS RD.                SE DECISION MADE: 10-JUL-12
TORONTO, ONTARIO    CA M3B 3P9    510(k) STATEMENT

DEVICE: CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM
I-SENS, INC.                      510(k) NO: K121133(SPECIAL)
ATTN: HYUN  JOON OH               PHONE NO : 822 916 6191
465-6 WOLGYE-DONG, NOWON-GU       SE DECISION MADE: 10-JUL-12
SEOUL    KS 139-845               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERFORMAX PEDIATRIC SE TOTAL FACE MASK
RESPIRONICS, INC.                 510(k) NO: K120639(TRADITIONAL)
ATTN: MICHELLE  BRINKER           PHONE NO : 724 387 4146   
365 PLUM INDUSTRIAL COURT         SE DECISION MADE: 10-JUL-12
PITTSBURGH PA 15239               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS
SYNERGETICS, INC                  510(k) NO: K121426(TRADITIONAL)
ATTN: GARY  OLIVEROS              PHONE NO : 636 794 5107   
3845 CORPORATE CENTRE DRIVE       SE DECISION MADE: 10-JUL-12
O'FALLON MO 63368                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIRECTPATH
CYBERNET SYSTEMS CO., LTD.        510(k) NO: K121449(TRADITIONAL)
ATTN: DIANE  SUDDUTH              PHONE NO : 512 327 9997   
611 WEST 5TH ST.                  SE DECISION MADE: 10-JUL-12
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS
LIGHTSCALPEL LLC                  510(k) NO: K121471(TRADITIONAL)
ATTN: GERALD S PALECKI            PHONE NO : 425 408 9477   
16932 WOOD-RED RD NE STE 201      SE DECISION MADE: 10-JUL-12
WOODINVILLE WA 98072              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: V5MS TRANSDUCER
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K121807(SPECIAL)
ATTN: SHELLY  PEARCE              PHONE NO : 650 694 5988   
2500 Millbrook Dr. Suite B        SE DECISION MADE: 10-JUL-12
Buffalo Grove IL 60089            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES
WEALTH ON (JIANGSU) CO., LTD      510(k) NO: K120584(TRADITIONAL)
ATTN: CHARLES  SHEN               PHONE NO : 001 608 2179358
5 CAREY ST                        SE DECISION MADE: 10-JUL-12
PENNINGTON NJ 08534               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM
SPINAL USA LLC                    510(k) NO: K112748(TRADITIONAL)
ATTN: FRANKIE  CUMMINS            PHONE NO : 601 420 4244   
2050 Executive Dr                 SE DECISION MADE: 11-JUL-12
Pearl MS 39208                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDSOURCE IV ADMINSTRATION SET
MEDSOURCE INTERNATIONAL, LLC.     510(k) NO: K120424(TRADITIONAL)
ATTN: JENNIFER  NESS              PHONE NO : 952 472 0131   
5346 SHORELINE DRIVE              SE DECISION MADE: 11-JUL-12
MOUND MN 55318                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONGOOSE ANGIOGRAPHIC CATHETER
PEDIACATH INC.                    510(k) NO: K113819(TRADITIONAL)
ATTN: CAROLINE  TONTINI           PHONE NO : 512 327 9997   
611 WEST 5TH STREET               SE DECISION MADE: 11-JUL-12
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO
THE BINDING SITE GROUP LTD        510(k) NO: K113349(TRADITIONAL)
ATTN: MARIANNE  SENDER            PHONE NO : 440 121 4569500
8 CALTHORPE ROAD EDGBASTON        SE DECISION MADE: 11-JUL-12
BIRMINGHAM, WEST MIDLANDS    UK B1510(k) STATEMENT

DEVICE: M/29TM - PRESSURE INJECTABLE
FLEXICATH LTD.                    510(k) NO: K111939(TRADITIONAL)
ATTN: TALI  HAZAN                 PHONE NO : 972 50 5292304
120 YIGAL ALON ST. CALIFORNIA BLDGSE DECISION MADE: 11-JUL-12
TEL AVIV    IS 67443              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GYMFORM DUAL FLEX BELT MODEL WB-162
WELL BRAIN INTERNATIONAL, LTD.    510(k) NO: K111781(TRADITIONAL)
ATTN: VICTOR K WAI                PHONE NO : 852 261 90833
100 GRANVILLE ROAD TSIM SHA TSUI ESE DECISION MADE: 11-JUL-12
HONG KONG, SAR CHINA    CH CH     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINICAT
XORAN TECHNOLOGIES, INC.          510(k) NO: K113421(SPECIAL)
ATTN: MARTHA  RUMFORD             PHONE NO : 734 418 5156   
5210 South State Road             SE DECISION MADE: 11-JUL-12
Ann Arbor MI 48108                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIQUICHEK URINE CHEMISTRY CONTROL
BIO-RAD, DIAGNOSTICS GRP.         510(k) NO: K121794(TRADITIONAL)
ATTN: SUZANNE  PARSONS            PHONE NO : 949 598 1467   
9500 JERONIMO RD.                 SE DECISION MADE: 11-JUL-12
IRVINE CA 92618 2017              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POISE PERSONAL LUBRICANT
KIMBERLY-CLARK CORPORATION        510(k) NO: K120650(TRADITIONAL)
ATTN: SWARNA  MUKUND              PHONE NO : 770 587 8083   
1400 HOLCOMB BRIDGE RD.           SE DECISION MADE: 11-JUL-12
ROSWELL GA 30076                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)
RANDOX LABORATORIES, LTD.         510(k) NO: K121746(TRADITIONAL)
ATTN: PAULINE  ARMSTRONG          PHONE NO : 44 0 2894422413
55 DIAMOND RD.                    SE DECISION MADE: 11-JUL-12
CRUMLIN, COUNTY ANTRIM    UK BT29 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION
C.R. BARD, INC.                   510(k) NO: K121856(SPECIAL)
ATTN: ERIN  FOX                   PHONE NO : 480 379 2841   
1625 WEST 3RD ST.                 SE DECISION MADE: 11-JUL-12
TEMPE AZ 85281 1740               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM
LIEBEL-FLARSHEIM                  510(k) NO: K121838(TRADITIONAL)
ATTN: CRAIG  BUEHLER              PHONE NO : 314 654 3188   
2111 EAST GALBRAITH RD            SE DECISION MADE: 11-JUL-12
CINCINNATI OH 45237               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: AC LENS BRANDED CONTACT LENS CASE
ARLINGTON CONTACT LENS SERVICES,IN510(k) NO: K120969(TRADITIONAL)
ATTN: CHRISTIAN  SMITH            PHONE NO : 888 729 9674   
1468 HARWELL AVE.                 SE DECISION MADE: 11-JUL-12
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CS1000 LIGHT THERAPY DEVICE
GENESIS HEALTH LIGHT CORPORATION  510(k) NO: K110558(TRADITIONAL)
ATTN: PAUL  ZIEMER                PHONE NO : 289 895 8479
7 INNOVATION DRIVE SUITE 102      SE DECISION MADE: 12-JUL-12
HAMILTON, ONTARIO    CA L9H 7H9   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MYRIAN 1.11
INTRASENSE                        510(k) NO: K113620(TRADITIONAL)
ATTN: FREDERIC  BANEGAS           PHONE NO : 334 671 30130
1231 AVENUE DU MONDIAL 98         SE DECISION MADE: 12-JUL-12
MONTPELLIER    FR 34000           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT
ALFA WASSERMANN                   510(k) NO: K113436(TRADITIONAL)
ATTN: HYMAN  KATZ                 PHONE NO : 973 852 0158   
4 Henderson Drive                 SE DECISION MADE: 12-JUL-12
Caldwell NJ 07006                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARROW REVERSE SHOULDER SYSTEM
FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K112193(TRADITIONAL)
ATTN: PATRICIA  DONNARD           PHONE NO : 332 985 56895
ZI DE KERNEVEZ-6 RUE NOBEL        SE DECISION MADE: 12-JUL-12
QUIMPER    FR 29000               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLACK NITRILE POWDER-FREE EXAMINATION GLOVES
NORTHSTAR HEALTHCARE HOLDINGS     510(k) NO: K121529(TRADITIONAL)
ATTN: WESLEY  TOAVS               PHONE NO : 441 278 3827
HAMILTON HOUSE, 10 QUEEN ST       SE DECISION MADE: 12-JUL-12
HAMILTON, BERMUDA    EI HM11      510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: 0.9% SODIUM CHLORIDE FLISH SYRINGE
AMUSA                             510(k) NO: K120836(SPECIAL)
ATTN: KAREN  THOMISON             PHONE NO : 615 833 2633   
5209 Linbar Dr Ste 640            SE DECISION MADE: 12-JUL-12
NASHVILLE TN 37211                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER
BIOPSY SCIENCES, LLC              510(k) NO: K121113(TRADITIONAL)
ATTN: SHARON  ROCKWELL            PHONE NO : 727 290 9825   
5582 CHALON RD.                   SE DECISION MADE: 12-JUL-12
YORBA LINDA FL 33760              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE
ARTHOCARE CORPORATION             510(k) NO: K121306(TRADITIONAL)
ATTN: CHERYL  FREDERICK           PHONE NO : 512 358 5751   
7000 WEST WILLIAM CANNON DRIVE BUISE DECISION MADE: 12-JUL-12
AUSTIN TX 78735                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRESSON ELECTRODE
RHYTHMLINK INTERNATIONAL, LLC     510(k) NO: K121347(TRADITIONAL)
ATTN: JAMES  MEWBORNE             PHONE NO : 803 252 1222   
1140 FIRST ST. SOUTH              SE DECISION MADE: 12-JUL-12
Columbia SC 29209                 510(k) STATEMENT

DEVICE: BW685, BW685S
BIEGLER GMBH                      510(k) NO: K121198(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DR                 SE DECISION MADE: 12-JUL-12
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RENAISSANCE
MAZOR ROBOTICS LTD                510(k) NO: K120812(TRADITIONAL)
ATTN: AHAVA  STEIN                PHONE NO : 972 976700 02
20 HATA'AS ST. BOX 124 SUITE 213 BSE DECISION MADE: 12-JUL-12
KFAR SABA    IS 44425             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RI MSC (MIGRATION SEDIMENTATION CHAMBER)
RESEARCH INSTRUMENTS LTD.         510(k) NO: K112413(TRADITIONAL)
ATTN: DAVID  LANSDOWNE            PHONE NO : 44 132 6372753
BICKLAND INDUSTRIAL PARK          SE DECISION MADE: 13-JUL-12
FALMOUTH,  CORNWALL    UK TR11 4TA510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRUX VENA CAVA FILTER SYSTEM
CRUX BIOMEDICAL                   510(k) NO: K120402(TRADITIONAL)
ATTN: ELISA  HEBB                 PHONE NO : 650 321 9903   
1455 ADAMS DRIVE, #1170           SE DECISION MADE: 13-JUL-12
MENLO PARK CA 94025               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK
FOCUS DIAGNOSTICS, INC.           510(k) NO: K120413(TRADITIONAL)
ATTN: TARA  VIVIANI               PHONE NO : 562 240 6115   
11331 Valley View Street          SE DECISION MADE: 13-JUL-12
CYPRESS CA 90630                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR
SEEBREATH AB                      510(k) NO: K112840(TRADITIONAL)
ATTN: ANETTE  SJOGREN             PHONE NO : 460 462 5358
MORKULLEVAGEN 31                  SE DECISION MADE: 13-JUL-12
BJARRED    SW 23736               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLANCET
MICROPOINT TECHNOLOGIES PTE LTD   510(k) NO: K113513(TRADITIONAL)
ATTN: CHEE Y LIM                  PHONE NO : 656 777 0573
11, KALLANG PLACE #06-10/12       SE DECISION MADE: 13-JUL-12
SINGAPORE    SN 339155            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM
INFOPIA CO., LTD                  510(k) NO: K113192(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 869 3080   
951 STARBUCK ST. UNIT J           SE DECISION MADE: 13-JUL-12
FULLERTON CA 92833                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,
TOSAMA D.O.O.                     510(k) NO: K120481(SPECIAL)
ATTN: MARJETKA  KRALJ KUNCIC      PHONE NO : 386 172 90370
SARANOVICEVA CESTA 035            SE DECISION MADE: 13-JUL-12
VIR, DOMZALE    SI 1230           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT
ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K113374(TRADITIONAL)
ATTN: HYMAN  KATZ                 PHONE NO : 973 852 0158   
4 HENDERSON DRIVE                 SE DECISION MADE: 13-JUL-12
WEST CALDWELL NJ 07006            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLEXITIME MONOPHASE PRO SCAN
HERAEUS KULZER, LLC               510(k) NO: K113574(TRADITIONAL)
ATTN: CHRIS  HOLDEN               PHONE NO : 574 299 5400   
300 HERAEUS WAY                   SE DECISION MADE: 13-JUL-12
SOUTH BEND IN 46614               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONICA AN24
MONICA HEALTHCARE LTD.            510(k) NO: K112390(TRADITIONAL)
ATTN: IAN  HOW                    PHONE NO : 44 115 9124540
BIOCITY, PENNYFOOT STREET         SE DECISION MADE: 13-JUL-12
NOTTINGHAM    UK NG1 1GF          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES
LSI SOLUTIONS, INC.               510(k) NO: K111014(TRADITIONAL)
ATTN: JUDE S SAUER, M.D.          PHONE NO : 585 869 6608   
7796 VICTOR-MENDON RD.            SE DECISION MADE: 13-JUL-12
NEW YORK NY 14564                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE
ACUMED LLC                        510(k) NO: K120903(SPECIAL)
ATTN: BRITTANY  CUNNINGHAM        PHONE NO : 503 207 1467   
5885 NW CORNELIUS PASS RD.        SE DECISION MADE: 13-JUL-12
HILLSBORO OR 97124 9432           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPNOGRAPHY PAD (92516)
SPACELABS HEALTHCARE              510(k) NO: K121017(SPECIAL)
ATTN: THOMAS  KROENKE             PHONE NO : 303 956 4232   
P.O. BOX 3018                     SE DECISION MADE: 13-JUL-12
NEDERLAND CO 80466                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
MEDTRONIC INC.                    510(k) NO: K121767(SPECIAL)
ATTN: MARY E DONLIN               PHONE NO : 763 526 9172   
8200 CORAL SEA STREET NE          SE DECISION MADE: 13-JUL-12
MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)
ANGIOTECH                         510(k) NO: K120827(TRADITIONAL)
ATTN: KIRSTEN  STOWELL            PHONE NO : 610 404 1000   
100 DENNIS DRIVE                  SE DECISION MADE: 13-JUL-12
READING PA 19606                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFILL INTERVERTEBRAL BODY FUSION DEVICE
PINNACLE SPINE GROUP, LLC         510(k) NO: K121733(SPECIAL)
ATTN: REBECCA K PINE              PHONE NO : 760 809 5178   
1601 Elm St Ste 300               SE DECISION MADE: 13-JUL-12
Dallas TX 75201                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER
ACTA MEDICAL LLC                  510(k) NO: K121161(TRADITIONAL)
ATTN: AARON  COMPTON              PHONE NO : 214 533 1416   
929 ARBOR DOWNS SR                SE DECISION MADE: 13-JUL-12
PLANO TX 75023                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESIN 11
RESPINNOVATION SAS                510(k) NO: K121170(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 13-JUL-12
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MANTARAY GUIDEWIRES
BRIDGEPOINT MEDICAL               510(k) NO: K121745(SPECIAL)
ATTN: JILL  MUNSINGER             PHONE NO : 763 225 8500   
13355 10TH AVE N, SUITE #110      SE DECISION MADE: 13-JUL-12
PLYMOUTH MN 55441                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIGNET TELEHEALTH MANAGER
VIGNET INC.                       510(k) NO: K113446(TRADITIONAL)
ATTN: CARLOS  GONZALEZ            PHONE NO : 925 209 6605   
7833 KNOLLBROOK DR.               SE DECISION MADE: 16-JUL-12
PLEASANTON CA 94588               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3MP COLOR LCD MONITOR, RADIFORCE RX340
EIZO NANAO CORPORATION            510(k) NO: K113562(TRADITIONAL)
ATTN: HIROAKI  HASHIMOTO          PHONE NO : 817 627 42468
153 SHIMOKASHIWANO, HAKUSAN       SE DECISION MADE: 16-JUL-12
ISHIKAWA    JA 924-8566           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIO 7
BIONET CO., LTD.                  510(k) NO: K113306(TRADITIONAL)
ATTN: MARC  GOODMAN               PHONE NO : 949 398 5222   
5405 ALTON PARKWAY, SUITE A530    SE DECISION MADE: 16-JUL-12
IRVINE CA 92604                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEARTRAIL III GUIDING CATHETER
TERUMO CORPORATION                510(k) NO: K113335(SPECIAL)
ATTN: MARK  UNTERREINER           PHONE NO : 410 392 7213
44-1, 2-CHOME HATAGAYA            SE DECISION MADE: 16-JUL-12
SHIBUYA-KU TOKYO    JA 151-0072   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)
ELCAM MEDICAL A.C.A.L.            510(k) NO: K120253(TRADITIONAL)
ATTN: AHARON  COHEN               PHONE NO : 972 469 88120/1/2
KIBBUTZ BAR-AM                    SE DECISION MADE: 16-JUL-12
D.N. MEROM HAGALIL    IS 13860    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CALYPSO SYSTEM
HOGAN LOVELLS US LLP              510(k) NO: K120564(TRADITIONAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET ST 29TH FL            SE DECISION MADE: 16-JUL-12
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE
ETHICON ENDO-SURGERY, LLC         510(k) NO: K121600(TRADITIONAL)
ATTN: ASIFA  VONHOF               PHONE NO : 513 337 3118   
4545 CREEK ROAD                   SE DECISION MADE: 16-JUL-12
CINCINNATI OH 45242               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE  HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA
HSINER COMPANY                    510(k) NO: K120920(TRADITIONAL)
ATTN: TOM  SHANKS                 PHONE NO : 951 506 2674   
29201 VIA NORTE                   SE DECISION MADE: 16-JUL-12
TEMECULA CA 92591                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTOMY IRRIGATION SET
COLOPLAST A/S                     510(k) NO: K121833(SPECIAL)
ATTN: TIM  CRABTREE               PHONE NO : 612 302 4922   
1601 WEST RIVER ROAD N            SE DECISION MADE: 16-JUL-12
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGNETOM SPECTRA
SIEMENS MEDICAL SOLUTIONS USA INC.510(k) NO: K121160(TRADITIONAL)
ATTN: NADIA  SOOKDEO              PHONE NO : 610 448 4918   
51 VALLEY STREAM PARKWAY          SE DECISION MADE: 16-JUL-12
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER
CHANGZHOU KANGDI MEDICAL STAPLER C510(k) NO: K121474(TRADITIONAL)
ATTN: CHARLES  MACK               PHONE NO : 931 625 4938   
77325 JOYCE WAY                   SE DECISION MADE: 16-JUL-12
ECHO OR 97826                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM
NUVASIVE, INC.                    510(k) NO: K121837(SPECIAL)
ATTN: CYNTHIA  ADAMS              PHONE NO : 858 320 4549   
7475 LUSK BLVD                    SE DECISION MADE: 16-JUL-12
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
POLYMED THERAPEUTICS, INC         510(k) NO: K112101(TRADITIONAL)
ATTN: FENG-YU  LEE                PHONE NO : 949 951 3046   
27001 LA PAZ ROAD, SUITE 266B     SE DECISION MADE: 17-JUL-12
MISSION VIEJO CA 92691            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCU-CHECK COMBO SYSTEM
ROCHE DIAGNOSTICS                 510(k) NO: K111353(ABBREVIATED)
ATTN: SCOTT  THIEL                PHONE NO : 317 274 1100   
9115 HAGUE ROAD                   SE DECISION MADE: 17-JUL-12
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: A&J 5L POCA SERIES OXYGEN CONCENTRATOR
ZHONGSHAN A&J MEDICAL EQUIPMENT CO510(k) NO: K121531(TRADITIONAL)
ATTN: JUNHONG  AN                 PHONE NO : 867 602 3130562
3 SHENGHUI SOUTH ROAD NANTOU TOWN,SE DECISION MADE: 17-JUL-12
GUANGDONG    CH                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TIO2MESH TM
BIOCER ENTWICKLUNGS GMBH          510(k) NO: K113311(TRADITIONAL)
ATTN: CHERYL  FISHER              PHONE NO : 408 410 5920   
611 WEST 5TH ST. THIRD FLOOR      SE DECISION MADE: 17-JUL-12
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESOLVE BILIARY LOCKING DRAINAGE CATHETER
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K121832(SPECIAL)
ATTN: CASEY  HUGHES               PHONE NO : 801 316 4932   
1600 WEST MERIT PKWY.             SE DECISION MADE: 17-JUL-12
South Jordan UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERFORMAX PEDIATRIC EE TOTAL FACE MASK
RESPIRONICS, INC.                 510(k) NO: K120562(TRADITIONAL)
ATTN: MICHELLE  BRINKER           PHONE NO : 724 387 4146   
365 PLUM INDUSTRIAL COURT         SE DECISION MADE: 17-JUL-12
PITTSBURGH PA 15239               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NMI MICROCATHETER
NAVILYST MEDICAL, INC.            510(k) NO: K121954(SPECIAL)
ATTN: WANDA  CARPINELLA           PHONE NO : 508 658 7929   
26 FOREST STREET                  SE DECISION MADE: 17-JUL-12
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON-CONTACT CLINICAL THERMOMETER
RADIANT INNOVATION INC.           510(k) NO: K121428(TRADITIONAL)
ATTN: JAMES  HUANG                PHONE NO : 886 3 6111666
1F, NO.3, INDUSTRIAL E. 9TH RD SCISE DECISION MADE: 17-JUL-12
HSINCHU    TW 30075               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MERIDIAN CRANIAL PERFORATOR
ADEOR MEDICAL TECHNOLOGIES GMBH   510(k) NO: K121253(TRADITIONAL)
ATTN: FABIO  VON  ZEPPELIN        PHONE NO : 004 908 974442398
KIRCHPLATZ 1                      SE DECISION MADE: 17-JUL-12
PULLACH    GM 82049               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTELLIVUE PATIENT MONITOR
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K120366(ABBREVIATED)
ATTN: MARKUS  STACHA              PHONE NO : 497 031 4632842
HEWLETT-PACKARD STR.2             SE DECISION MADE: 18-JUL-12
BOEBLINGEN    GM D 71034          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONNECTED CARE MOBILE APPLICATION
WATERMARK MEDICAL                 510(k) NO: K120325(TRADITIONAL)
ATTN: MICHAEL J LEIGH             PHONE NO : 262 957 6797   
12715 FALCON DRIVE                SE DECISION MADE: 18-JUL-12
BROOKFIELD WI 53005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: U2 ACETABULAR CUP, PLASMA SPRAY
UNITED ORTHOPEDIC CORP.           510(k) NO: K121777(SPECIAL)
ATTN: FANG-YUAN  HO               PHONE NO : 886 3 5773351
57 PARK AVE. 2, SCIENCE PARK      SE DECISION MADE: 18-JUL-12
HSINCHU    TW 300                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSUFLOW SYNERGY PORT
LEXION MEDICAL, LLC.              510(k) NO: K120640(TRADITIONAL)
ATTN: BERNARD  HORWATH            PHONE NO : 651 361 8041   
5000 TOWNSHIP PKWY                SE DECISION MADE: 18-JUL-12
ST. PAUL MN 55110                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
ZIMMER SPINE, INC.                510(k) NO: K121671(TRADITIONAL)
ATTN: DAVID  PADGETT              PHONE NO : 512 533 1998   
5301 Riata Park Court, Building F SE DECISION MADE: 18-JUL-12
AUSTIN TX 78727                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: M.U.S.T PEDICLE SCREW SYSTEM
MEDACTA INTERNATIONAL             510(k) NO: K121115(TRADITIONAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 437 7085   
4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 18-JUL-12
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE
MEDICREA INTERNATIONAL            510(k) NO: K121323(TRADITIONAL)
ATTN: LAURE  AVIRON-VIOLET        PHONE NO : 33 4 72018787
14 Porte du Grand Lyon            SE DECISION MADE: 18-JUL-12
NEYRON    FR 01700                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3.9MM REELX STT SUTURE ANCHOR SYSTEM
STRYKER CORP.                     510(k) NO: K120824(TRADITIONAL)
ATTN: KELLY  KUCHARCZYK           PHONE NO : 201 831 6455   
3201 E. 3RD AVE                   SE DECISION MADE: 18-JUL-12
DENVER CO 80206                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER
EXTREMITY MEDICAL LLC             510(k) NO: K121349(SPECIAL)
ATTN: JAMY  GANNOE                PHONE NO : 973 588 8980   
300 INTERPACE PARKWAY SUITE 410   SE DECISION MADE: 18-JUL-12
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ST80I STRESS TEST SYSTEM
PHILIPS HEALTHCARE                510(k) NO: K121638(TRADITIONAL)
ATTN: GRETAL  LUMLEY              PHONE NO : 805 214 5101   
1525 RANCHO CONEJO BLVD SUITE 100 SE DECISION MADE: 18-JUL-12
THOUSAND OAKS CA 91320            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM
EXTREMITY MEDICAL LLC             510(k) NO: K121417(SPECIAL)
ATTN: JAMY  GANNOE                PHONE NO : 973 588 8980   
300 INTERPACE PARKWAY SUITE 410   SE DECISION MADE: 18-JUL-12
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIO PATCH
IRHYTHM TECHNOLOGIES, INC.        510(k) NO: K121319(TRADITIONAL)
ATTN: MICHAEL  RIGHTER            PHONE NO : 415 632 5738   
650 TOWNSEND STREET SUITE 380     SE DECISION MADE: 18-JUL-12
SAN FRANCISCO CA 94103            510(k) STATEMENT

DEVICE: WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
SEJOY ELECTRONICS & INSTRUMENTS CO510(k) NO: K121355(TRADITIONAL)
ATTN: REN  YUNHUA                 PHONE NO : 865 718195 7767
WEST LAKE ECONOMY & TECHNOLOGY ZONSE DECISION MADE: 18-JUL-12
HANGZHOU, ZHEJIANG    CH 310030   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLARIS Q-SWITCH RUBY SYSTEM
SANDSTONE MEDICAL TECHNOLOGIES, LL510(k) NO: K121162(TRADITIONAL)
ATTN: MARK  ROHRER                PHONE NO : 205 290 8251   
105 Citation Court                SE DECISION MADE: 18-JUL-12
HOMEWOOD AL 35209                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPNOSTREAM20P WITH AI/ODI
ORIDION MEDICAL 1987 LTD.         510(k) NO: K112368(TRADITIONAL)
ATTN: RACHEL  WEISSBROD           PHONE NO : 972 258 99115
7 HAMARPE STREET, HAR HOTZVIM INDUSE DECISION MADE: 19-JUL-12
JERUSALEM    IS 91450             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACE ALT REAGENT
ALFA WASSERMANN                   510(k) NO: K113382(TRADITIONAL)
ATTN: HYMAN  KATZ                 PHONE NO : 973 852 0158   
4 Henderson Drive                 SE DECISION MADE: 19-JUL-12
Caldwell NJ 07006                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HANDHELD ECG MONITOR
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K112622(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 212 2815850
P.O. BOX 237-023                  SE DECISION MADE: 19-JUL-12
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CFR QUANT
UNIVERSITY OF TEXAS MEDICAL SCHOOL510(k) NO: K113754(TRADITIONAL)
ATTN: K. LANCE  GOULD             PHONE NO : 713 500 6611   
6431 FANNIN ST. ROOM MSB 4.256    SE DECISION MADE: 19-JUL-12
HOUSTON TX 77030                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE
HANGZHOU BEVER MEDICAL DEVICES CO.510(k) NO: K111401(TRADITIONAL)
ATTN: ALLYSON  ZHOU               PHONE NO : 86 571 88616630
NO. 8-1, LONGQUAN ROAD CANGQIAN TOSE DECISION MADE: 19-JUL-12
HANGZHOU, ZHEJIANG    CH 311121   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL)
HANGZHOU BEVER MEDICAL DEVICES CO.510(k) NO: K111406(TRADITIONAL)
ATTN: ALLYSON  ZHOU               PHONE NO : 86 571 88616630
NO. 8-1, LONGQUAN ROAD CANGQIAN TOSE DECISION MADE: 19-JUL-12
HANGZHOU, ZHEJIANG    CH 311121   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING
SMITH & NEPHEW, INC.              510(k) NO: K120211(TRADITIONAL)
ATTN: JOHN  CONNOR                PHONE NO : 901 399 5944   
1450 BROOKS RD.                   SE DECISION MADE: 19-JUL-12
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)
HOLOGIC, INC.                     510(k) NO: K121868(SPECIAL)
ATTN: SARAH  FAIRFIELD            PHONE NO : 508 263 8857   
250 CAMPUS DRIVE                  SE DECISION MADE: 19-JUL-12
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROCARE MONITOR B40
GE MEDICAL SYSTEMS CHINA CO., LTD.510(k) NO: K120598(TRADITIONAL)
ATTN: ROBERT  CASARSA             PHONE NO : 414 362 3063   
8200 WEST TOWER AVE               SE DECISION MADE: 19-JUL-12
MILWAUKEE WI 53223                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORPATH 200 SYSTEM
CORINDUS INC.                     510(k) NO: K120834(TRADITIONAL)
ATTN: MONA  ADVANI                PHONE NO : 410 674 2060   
5523 RESEARCH PARK DRIVE SUITE 110SE DECISION MADE: 19-JUL-12
BALTIMORE MD 21228                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RSCRIBE ELECTROCARDIOGRAPH
MORTARA INSTRUMENT, INC           510(k) NO: K120865(SPECIAL)
ATTN: CHARLES  MORREALE           PHONE NO : 414 354 1600   
7865 NORTH 86TH STREET            SE DECISION MADE: 19-JUL-12
MILWAUKEE WI 53224                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM
BIOJECT MEDICAL TECHNOLOGIES INC. 510(k) NO: K121270(TRADITIONAL)
ATTN: CHRISTINE  BREITBACH        PHONE NO : 503 692 8001   
7180 SW Sandburg St Ste 100       SE DECISION MADE: 19-JUL-12
Tigard OR 97223                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE)
TANGSHAN ZHONGHONG PULIN PLASTIC C510(k) NO: K120970(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
RM 1606 BLDG 1 JIANXIANG YUAN NO.2SE DECISION MADE: 19-JUL-12
BEIJING    CH CH                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONTINUOUS SINGLE CULTURE COMPLETE
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K121572(TRADITIONAL)
ATTN: JAYME  YAMAGUCHI-OWENS      PHONE NO : 949 261 7800   
2511 DAIMLER ST                   SE DECISION MADE: 19-JUL-12
SANTA ANA CA 92705                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SLIDEWIRETM(TRADEMARK PENDING)
ACME-MONACO CORP.                 510(k) NO: K113162(TRADITIONAL)
ATTN: BENJAMIN  SWEENEY           PHONE NO : 860 224 1349   
75 WINCHELL DR.                   SE DECISION MADE: 20-JUL-12
NEW BRITAIN CT 06052              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING
C.R. BARD, INC.                   510(k) NO: K113229(TRADITIONAL)
ATTN: STEPHANIE  BAKER            PHONE NO : 401 825 8588   
100 CROSSINGS BOULEVARD           SE DECISION MADE: 20-JUL-12
WARWICK RI 02886                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE TORQUE DEVICE
COEUR, INC.                       510(k) NO: K113498(TRADITIONAL)
ATTN: DEBRA F MANNING             PHONE NO : 615 547 7923   
100 PHYSICIANS WAY SUITE 200      SE DECISION MADE: 20-JUL-12
LEBANON TN 37090                  510(k) STATEMENT

DEVICE: SURGICASE CONNECT, SURGICASE GUIDE
MATERIALISE N.V.                  510(k) NO: K112389(TRADITIONAL)
ATTN: ALEXANDRA  RAZZHIVINA       PHONE NO : 32 163 96280
TECHNOLOGIELAAN 15                SE DECISION MADE: 20-JUL-12
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERSAVUE ENTERPRISE SUITE
ICAD, INC.                        510(k) NO: K121517(SPECIAL)
ATTN: MICHAEL A PATZ              PHONE NO : 603 882 5200   
98 SPIT BROOK ROAD SUITE 100      SE DECISION MADE: 20-JUL-12
NASHUA NH 03062                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYBRID ARCTICGEL PAD
MEDIVANCE, INC.                   510(k) NO: K120849(TRADITIONAL)
ATTN: LYNNE  ARONSON              PHONE NO : 303 926 1917   
321 SOUTH TAYLOR AVENUE SUITE 200 SE DECISION MADE: 20-JUL-12
LOUISVILLE CO 80027               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE
ENCORE MEDICAL, L.P.              510(k) NO: K121835(SPECIAL)
ATTN: MICHAELA  NORRIS            PHONE NO : 512 834 6291   
9800 METRIC BLVD.                 SE DECISION MADE: 20-JUL-12
AUSTIN TX 78758                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVACATH SECURE IV CATHETER SYSTEM-18G
TANGENT MEDICAL TECHNOLOGIES, INC.510(k) NO: K120839(TRADITIONAL)
ATTN: KAY  FULLER                 PHONE NO : 734 527 4060   
8170 JACKSON RD, STE A            SE DECISION MADE: 20-JUL-12
ANN ARBOR MI 48103                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CR 10-X DIGITIZER
PRACTICAL COMPLIANCE, LLC         510(k) NO: K121948(SPECIAL)
ATTN:                             PHONE NO : 
P.O. BOX 1927                     SE DECISION MADE: 20-JUL-12
BREVARD NC 28712 1927             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM)
ORTHOFIX INC.                     510(k) NO: K121658(TRADITIONAL)
ATTN: ALLY  BADUEL                PHONE NO : 214 937 2000   
3451 Plano Parkway                SE DECISION MADE: 20-JUL-12
Lewisville TX 75056               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GMK SPHERE
MEDACTA INTERNATIONAL             510(k) NO: K121416(TRADITIONAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 437 7085   
4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 20-JUL-12
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GEMORE TENS SYSTEM
GEMORE TECHNOLOGY CO., LTD.       510(k) NO: K120569(ABBREVIATED)
ATTN: BODEN S.P.  LAI             PHONE NO : 866 288 091799
11 FL, NO. 29-5, SEC. 2 CHUNG CHENSE DECISION MADE: 20-JUL-12
TAN SHUI, TAIPEI HSIEN    TW 251  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)
BOVIE MEDICAL CORPORATION         510(k) NO: K121441(TRADITIONAL)
ATTN: RICHARD A KOZLOFF           PHONE NO : 727 384 2323   
5115 Ulmerton Road --             SE DECISION MADE: 20-JUL-12
Clearwater FL 33760 0000          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER
INTEGRA LIFESCIENCE CORPORTATION  510(k) NO: K121159(TRADITIONAL)
ATTN: STEVEN  PELTIER             PHONE NO : 609 936 2309   
311 ENTERPRISE DRIVE              SE DECISION MADE: 20-JUL-12
PLAINSBORO NJ 08536               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CASIAN, 3.5/4.5 CONNECTORS
K2M, INC.                         510(k) NO: K121808(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR.,SE                 SE DECISION MADE: 20-JUL-12
LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION
AMERICAN MEDICAL SYSTEMS          510(k) NO: K121612(SPECIAL)
ATTN: NGOC LINH  PHAM LATCHMAN    PHONE NO : 952 939 7023   
10700 BREN ROAD WEST              SE DECISION MADE: 20-JUL-12
MINNETONKA MN 55343               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Z6 DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K122010(TRADITIONAL)
ATTN: YANG  ZHAOHUI               PHONE NO : 867 558 1885604
MINDRAY BUILDING, KEJI 12TH ROAD SSE DECISION MADE: 20-JUL-12
SHENZHEN    CH 518057             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
SORIN GROUP ITALIA S.R.L.         510(k) NO: K121229(TRADITIONAL)
ATTN: BARRY  SALL                 PHONE NO : 781 434 4742   
195 WEST STREET                   SE DECISION MADE: 23-JUL-12
WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K121907(TRADITIONAL)
ATTN: ROSE T MARINELLI            PHONE NO : 302 631 8805   
P.O. BOX 6101, MAILSTAP 514       SE DECISION MADE: 23-JUL-12
NEWARK DE 19714                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIO 5MP
BARCO NV                          510(k) NO: K121788(TRADITIONAL)
ATTN: LIEVEN  DE WANDEL           PHONE NO : 32 56 233459
35 PRESIDENT KENNEDYPARK          SE DECISION MADE: 23-JUL-12
KORTRIJK    BE 8500               510(k) STATEMENT

DEVICE: ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5
ROCHE DIAGNOSTICS                 510(k) NO: K113546(TRADITIONAL)
ATTN: MICHAEL  LEUTHER            PHONE NO : 317 521 3930   
9115 HAGUE ROAD                   SE DECISION MADE: 24-JUL-12
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPRESSION CARE FLIGHT
MEDICAL MINDS LLC                 510(k) NO: K121376(TRADITIONAL)
ATTN: DAVID  PLATT                PHONE NO : 616 308 2859   
11491 78TH AVE.                   SE DECISION MADE: 24-JUL-12
ALLENDALE MI 49401                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: O2PAK OXYGEN GENERATOR
PACIFIC PRECISION PRODUCTS        510(k) NO: K120566(TRADITIONAL)
ATTN: GERALD  WHITE               PHONE NO : 949 727 3844   
9671 IRVINE CENTER DRIVE          SE DECISION MADE: 24-JUL-12
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONE-TROL LIQUID CHEMISTRY CONTROLS
CONE BIOPRODUCTS                  510(k) NO: K121759(ABBREVIATED)
ATTN: WILL  CONE                  PHONE NO : 830 379 0197   
1012 N Austin St                  SE DECISION MADE: 24-JUL-12
SEGUIN TX 78155                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROLUX/DL MICROLUX/BLU BIO/SCREEN
ADDENT, INC.                      510(k) NO: K121282(TRADITIONAL)
ATTN: JOSHUA  FRIEDMAN            PHONE NO : 203 778 0200   
43 MIRY BROOK RD.                 SE DECISION MADE: 24-JUL-12
DANBURY CT 06810                  510(k) STATEMENT

DEVICE: E1 EAR SENSORS
MASIMO CORPORATION                510(k) NO: K121912(SPECIAL)
ATTN: DAVID  COLLETTE             PHONE NO : 949 297 7000   
40 PARKER                         SE DECISION MADE: 24-JUL-12
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPOTHIXO
KERRHAWE SA                       510(k) NO: K111465(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 714 516 7602   
1717 WEST COLLINS AVENUE          SE DECISION MADE: 25-JUL-12
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENZZZZZ AWAY
CENTRIX, INC.                     510(k) NO: K120176(TRADITIONAL)
ATTN: LINDA K SCHULZ              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL STE 200      SE DECISION MADE: 25-JUL-12
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A
J. MORITA USA, INC.               510(k) NO: K120377(TRADITIONAL)
ATTN: KEITH A BARRITT             PHONE NO : 202 783 5070   
1425 K STREET NW SUITE 1100       SE DECISION MADE: 25-JUL-12
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARFIL MAJESTY FLOW
KURARAY NORITAKE DENTAL INC.      510(k) NO: K121583(TRADITIONAL)
ATTN: KIYOYUKI  ARIKAWA           PHONE NO : 212 986 2230   
33 MAIDEN LANE, 6TH FLOOR         SE DECISION MADE: 25-JUL-12
NEW YORK NY 10038                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT
MEDTRONIC INC.                    510(k) NO: K120988(SPECIAL)
ATTN: JACQUELINE  HAUGE           PHONE NO : 763 514 9967   
7611 NORTHLAND DRIVE              SE DECISION MADE: 25-JUL-12
BROOKLYN PARK MN 55428            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
NINEPOINT MEDICAL, INC            510(k) NO: K121195(SPECIAL)
ATTN: CINDY  DOMECUS              PHONE NO : 650 343 4813   
1171 BARROIHET AVENUE             SE DECISION MADE: 25-JUL-12
HILLSBOROUGH CA 94010             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLEXITIME FAST & SCAN LIGHT FLOW
HERAEUS KULZER, LLC               510(k) NO: K120914(SPECIAL)
ATTN: JAMIE  MEARNA               PHONE NO : 574 299 5421   
300 Heraeus Way                   SE DECISION MADE: 25-JUL-12
SOUTH BEND IN 46614               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K121557(TRADITIONAL)
ATTN: JOE  SHIA                   PHONE NO : 240 505 7880   
504 EAST DIAMOND AVE.             SE DECISION MADE: 25-JUL-12
SUITE F GAITHERSBURG MD 20877     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV
ROCHE DIAGNOSTICS                 510(k) NO: K120625(TRADITIONAL)
ATTN: K. COLLEEN  ADAMS           PHONE NO : 317 521 3577   
9115 HAGUE ROAD                   SE DECISION MADE: 25-JUL-12
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER
CONVATEC INC                      510(k) NO: K121275(TRADITIONAL)
ATTN: KATRINA  FIEDLER            PHONE NO : 908 904 2541   
200 HEADQUARTERS PARK DRIVE       SE DECISION MADE: 25-JUL-12
SKILLMAN NJ 08558                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TL TRISEB CREAM
TRIGEN LABORATORIES, INC.         510(k) NO: K121134(TRADITIONAL)
ATTN: MELISSA  GOODHEAD           PHONE NO : 813 671 8570   
11705 BOYETTE RD, STE 171         SE DECISION MADE: 25-JUL-12
RIVERVIEW FL 33569                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HLS UNI EVOLUTION & U-KNEETEC
TORNIER, INC.                     510(k) NO: K120262(TRADITIONAL)
ATTN: STEPHANIE  BERNARD          PHONE NO : 330 476 613500
161, RUE LAVOISIER SAINT ISMIER CESE DECISION MADE: 25-JUL-12
MONTBONNOT    FR 38334            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM
STRYKER CORP.                     510(k) NO: K121252(TRADITIONAL)
ATTN: ESTELA  CELI                PHONE NO : 201 831 6461   
325 CORPORATE DRIVE               SE DECISION MADE: 25-JUL-12
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES ZERO-P VARIABLE ANGLE (VA)
SYNTHES SPINE CO.LP               510(k) NO: K121852(SPECIAL)
ATTN: MONIKA  MCDOLE-RUSSELL      PHONE NO : 610 719 5448   
1302 WRIGHTS LANE EAST            SE DECISION MADE: 25-JUL-12
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER
COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K121510(TRADITIONAL)
ATTN: SARAH  RIZK                 PHONE NO : 203 492 6339   
60 Middletown Ave                 SE DECISION MADE: 25-JUL-12
North Haven CT 06473              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POSISEP AND POSISEP X HEMOSTAT DRESSINGS
HEMOSTASIS, LLC                   510(k) NO: K120958(TRADITIONAL)
ATTN: BERNARD  HORWATH            PHONE NO : 651 855 1466   
5000 Township Pkwy                SE DECISION MADE: 25-JUL-12
Saint Paul MN 55110               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAFETY INFUSION SET
GREINER BIO-ONE NORTH AMERICA, INC510(k) NO: K121908(SPECIAL)
ATTN: JUDITH  SMITH               PHONE NO : 410 592 2060   
P.O. BOX 103                      SE DECISION MADE: 25-JUL-12
BALDWIN MD 21013                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAREGUIDE OXIMETER
REFLECTANCE MEDICAL INC           510(k) NO: K113656(TRADITIONAL)
ATTN: NANDINI  MURTHY             PHONE NO : 781 710 5378   
116 FLAUNDERS ROAD, SUITE 1000    SE DECISION MADE: 26-JUL-12
WESTBOROUGH MA 01581              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LDR SPINE USA AVENUE L INTERBODY FUSION
LDR SPINE USA INC.                510(k) NO: K113285(TRADITIONAL)
ATTN: MARITZA  ELIAS              PHONE NO : 512 344 3471   
13785 RESEARCH BOULEVARD SUITE 200SE DECISION MADE: 26-JUL-12
AUSTIN TX 78750                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOBILE C-ARM
CANON, INC.-MEDICAL EQUIPMENT GROU510(k) NO: K121303(TRADITIONAL)
ATTN: DIANE  RUTHERFORD           PHONE NO : 972 480 9554   
1201 RICHARDSON DRIVE SUITE 280   SE DECISION MADE: 26-JUL-12
RICHARDSON TX 75080               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORIGEN REINFORCED DUAL LUMEN CATHETER
ORIGEN BIOMEDICAL                 510(k) NO: K113869(TRADITIONAL)
ATTN: RICHARD  MARTIN             PHONE NO : 512 474 7278   
7000 BURLESON ROAD BLDG D         SE DECISION MADE: 26-JUL-12
AUSTIN TX 78744                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUJINON COLONOSCOPES
FUJINON, INC.                     510(k) NO: K112391(SPECIAL)
ATTN: GINA  WALLJASPER            PHONE NO : 973 655 5600   
10 HIGH POINT DR.                 SE DECISION MADE: 26-JUL-12
WAYNE NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
ZEUS SCIENTIFIC, INC.             510(k) NO: K113397(TRADITIONAL)
ATTN: EWA  NADOLCZAK              PHONE NO : 908 526 3744   
200 EVANS WAY                     SE DECISION MADE: 26-JUL-12
BRANCHBURG NJ 08876               510(k) STATEMENT

DEVICE: PIONEER STERNAL ASSIST IMPLANT SYSTEM
PIONEER SURGICAL TECHNOLOGY, INC  510(k) NO: K120016(TRADITIONAL)
ATTN: SARAH  MCINTYRE             PHONE NO : 906 225 5861   
375 RIVER PARK CIRCLE             SE DECISION MADE: 26-JUL-12
Marquette MI 49855                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: A/C ENZYMATIC VITAMIN B6 ASSAY
ANTICANCER INC                    510(k) NO: K111260(TRADITIONAL)
ATTN: QINGHONG  HAN               PHONE NO : 858 654 2555   
7917 OSTROW ST.                   SE DECISION MADE: 26-JUL-12
SAN DIEGO CA 92111                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E-CUBE 15
ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K121888(TRADITIONAL)
ATTN: DONGHWAN  KIM               PHONE NO : 827 074 652068
1, 6 AND 7FL, VERDI TOWER 72, DIGISE DECISION MADE: 26-JUL-12
SEOUL    KS 152-848               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS
BIOMET CORPORATION                510(k) NO: K121183(TRADITIONAL)
ATTN: PATRICIA  SANDBORN BERES    PHONE NO : 574 267 6639   
56 EAST BELL DRIVE                SE DECISION MADE: 26-JUL-12
WARSAW IN 46580                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONNEX VITAL SIGNS MONITOR 6000 SERIES
WELCH ALLYN, INC.                 510(k) NO: K121013(SPECIAL)
ATTN: KEVIN  CROSSEN              PHONE NO : 315 685 2609   
4341 STATE ST. RD. P.O. BOX 220   SE DECISION MADE: 26-JUL-12
SKANEATELES FALLS NY 13153 0220   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WI-FI BODY SCALE
ANDON HEALTH CO., LTD             510(k) NO: K120896(TRADITIONAL)
ATTN: LIU  YI                     PHONE NO : 862 260 526161
No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 26-JUL-12
TIANJIN    CN 300190              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K120993(TRADITIONAL)
ATTN: VY  TRAN                    PHONE NO : 650 424 5731   
3100 HANSEN WAY                   SE DECISION MADE: 26-JUL-12
PALO ALTO CA 94304                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLARISCT
ICRCO INC.                        510(k) NO: K120753(TRADITIONAL)
ATTN: GREG  WACHTLER              PHONE NO : 310 921 9559   
2580 WEST 237TH STREET            SE DECISION MADE: 26-JUL-12
TORRANCE CA 90505                 510(k) STATEMENT

DEVICE: CONTOUR NEXT BLOOD GLUCOSE METER
BAYER HEALTHCARE LLC              510(k) NO: K121190(SPECIAL)
ATTN: CHARLES  RYAN               PHONE NO : 914 333 6122   
555 WHITE PLAINS RD.              SE DECISION MADE: 26-JUL-12
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CS-SERIES-FP WITH 3030+OPTION
OMEGA MEDICAL IMAGING, LLC        510(k) NO: K121293(TRADITIONAL)
ATTN: BRIAN J FLEMING             PHONE NO : 407 323 9400   
675 HICKMAN CIRCLE                SE DECISION MADE: 26-JUL-12
Sanford FL 32771                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NERVEVISION SOFTWARE SYSTEMS
3D IMAGING PARTNERS INC.          510(k) NO: K121075(TRADITIONAL)
ATTN: CAROLYN  PRIMUS             PHONE NO : 941 753 9737   
7046 OWL'S NEST TERRACE           SE DECISION MADE: 26-JUL-12
BRADENTON FL 34203                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER ALL SUTURE ANCHORS
STRYKER                           510(k) NO: K120509(TRADITIONAL)
ATTN: KELLY  KUCHARCZYK           PHONE NO : 201 831 6455   
3201 E. 3RD AVE                   SE DECISION MADE: 26-JUL-12
DENVER CO 80206                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROTARGETING XL STAR DRIVE SYSTEM
FHC, INC.                         510(k) NO: K121950(SPECIAL)
ATTN: KERI  SEITZ                 PHONE NO : 207 666 5651   
1201 MAIN ST                      SE DECISION MADE: 26-JUL-12
BOWDOIN ME 04287                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E-CUBE INNO
ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K121937(TRADITIONAL)
ATTN: DONGHWAN  KIM               PHONE NO : 827 074 652068
1, 6 AND 7FL, VERDI TOWER 72, DIGISE DECISION MADE: 26-JUL-12
SEOUL    KS 152-848               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S.C.O.R.E.S. UNIT
AMMED SURGICAL EQUIPMENT, LLC     510(k) NO: K110898(TRADITIONAL)
ATTN: DAVID C FURR                PHONE NO : 512 906 9654   
8708 CAPEHART COVE                SE DECISION MADE: 26-JUL-12
AUSTIN TX 78733                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR
SORIN GROUP ITALIA S.R.L.         510(k) NO: K121909(SPECIAL)
ATTN: SCOTT  LIGHT                PHONE NO : 303 467 6313   
14401 W. 65TH WAY                 SE DECISION MADE: 26-JUL-12
ARVADA CO 80004                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEACON STABILIZATION SYSTEM
GLOBUS MEDICAL INC.               510(k) NO: K121922(SPECIAL)
ATTN: MERIAM  YOUSSEF             PHONE NO : 610 930 1800   
2460 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 26-JUL-12
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ICP TRIAGEMANAGER
EMERGO EUROPE CONSULTING BV       510(k) NO: K122095(TRADITIONAL)
ATTN: RACHIDA  ZIANI              PHONE NO : 011 310703 458570
PRINSESSEGRACHT 20                SE DECISION MADE: 26-JUL-12
DEN HAAG    NL 2514               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
BIO-LOGIC SYSTEMS CORP.           510(k) NO: K121512(TRADITIONAL)
ATTN: DON  WILLIAMS               PHONE NO : 847 949 5200   
ONE BIOLOGIC PLAZA                SE DECISION MADE: 26-JUL-12
MUNDELEIN IL 60060                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQUILION RXL
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K121553(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 MICHELLE DRIVE               SE DECISION MADE: 26-JUL-12
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOVEREIGN SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK           510(k) NO: K121982(SPECIAL)
ATTN: LAUREN  KAMER               PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 26-JUL-12
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALERE PBP2A TEST
ALERE SCARBOROUGH, INC            510(k) NO: K121905(SPECIAL)
ATTN: ANGELA  DRYSDALE            PHONE NO : 207 730 5737   
10 SOUTHGATE ROAD                 SE DECISION MADE: 26-JUL-12
SCARBOROUGH ME 04074              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
SHANDONG SHOUGUANG KINGLIYUAN MEDI510(k) NO: K120797(TRADITIONAL)
ATTN: KEVIN  XU                   PHONE NO : 312 488 1785   
916 WEST 21ST STREET              SE DECISION MADE: 27-JUL-12
CHICAGO IL 60608                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HC-BIOS DENTAL IMPLANT
HUNG CHUN BIO-S CO., LTD.         510(k) NO: K110425(TRADITIONAL)
ATTN: MICHAEL  LEE                PHONE NO : 886 228 096995
NO.45, MINSHENG RD DANSHUI TOWN   SE DECISION MADE: 27-JUL-12
TAIPEI COUNTY    TW 251           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTIPLATE 5.0 AGGREGOMETER
VERUM DIAGNOSTICA GMBH            510(k) NO: K103555(TRADITIONAL)
ATTN: MAXIMILIAN  ZUCKER          PHONE NO : 490 891 255560
REICHENBACHSTRASSE 27             SE DECISION MADE: 27-JUL-12
MUNICH    GM 80469                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER
PROSPERA CORPORATION              510(k) NO: K113544(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
405 BOULDER CT SUITE 500          SE DECISION MADE: 27-JUL-12
PLEASANTON CA 94566               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORION
ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K113489(TRADITIONAL)
ATTN: ANTJE  KATZER               PHONE NO : 364 177 00309
BRUESSELER STR. 10                SE DECISION MADE: 27-JUL-12
JENA    GM 07747                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM
HMD BIOMEDICAL, INC.              510(k) NO: K113307(TRADITIONAL)
ATTN: JESSICA  TUNG               PHONE NO : 886 3 6017000
No 181 Minsheng St, Xinpu TownshipSE DECISION MADE: 27-JUL-12
Hsinchu County    TW 305          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOBEAM HOLMIUM LASER FIBERS
C.R. BARD, INC.                   510(k) NO: K120926(TRADITIONAL)
ATTN: TERRI  MORRIS               PHONE NO : 770 784 6994   
8195 INDUSTRIAL BLVD              SE DECISION MADE: 27-JUL-12
COVINGTON GA 30209                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EON CHOLESTEROL REAGENT
VITAL DIAGNOSTICS PTY. LTD        510(k) NO: K120202(TRADITIONAL)
ATTN: MELITA  LAMBIRIS            PHONE NO : 613 897 36300
189 - 199 BROWNS ROAD             SE DECISION MADE: 27-JUL-12
NOBLE PARK, VICTORIA    AS 3174   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE
SHANDONG TAIXIANG MEDICAL PRODUCTS510(k) NO: K120230(TRADITIONAL)
ATTN: RAY  ZHOU                   PHONE NO : 909 548 4828   
12390 EAST END AVE.               SE DECISION MADE: 27-JUL-12
CHINO CA 91710                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IO-TOME DEVICE
BAXANO, INC.                      510(k) NO: K113073(TRADITIONAL)
ATTN: EDWARD J SINCLAIR           PHONE NO : 408 514 2220   
655 River Oaks Pkwy               SE DECISION MADE: 27-JUL-12
San Jose CA 95134                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VEGA KNEE SYSTEM
AESCULAP IMPLANT SYSTEMS          510(k) NO: K121879(SPECIAL)
ATTN: JULIE  TOM WING             PHONE NO : 610 984 9147   
3773 CORPORATE PWKY.              SE DECISION MADE: 27-JUL-12
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IPS 99 ONE, IPS 99 CREAM
IVOCLAR VIVADENT AG               510(k) NO: K121359(TRADITIONAL)
ATTN: DONNA MARIE  HARTNETT       PHONE NO : 716 691 2260   
175 PINEVIEW DR.                  SE DECISION MADE: 27-JUL-12
AMHERST NY 14228                  510(k) STATEMENT

DEVICE: MOJO, VERASEAL
SLEEPNET CORPORATION              510(k) NO: K120463(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 27-JUL-12
BONITA SPRINGS FL 34134 2958      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM
ACCEL SPINE                       510(k) NO: K121569(TRADITIONAL)
ATTN: DANIEL  CHON                PHONE NO : 800 713 9489   
14850 Quorum Dr Ste 220           SE DECISION MADE: 27-JUL-12
Dallas TX 75254                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSICARDIAC
DIACOUSTIC MEDICAL (PTY)          510(k) NO: K121617(TRADITIONAL)
ATTN: YOLANDA  SMITH              PHONE NO : 888 729 9674   
1468 HARWELL AVE                  SE DECISION MADE: 27-JUL-12
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT
OBP CORPORATION                   510(k) NO: K121604(TRADITIONAL)
ATTN: JASON  SWIFT                PHONE NO : 888 300 2946   
360 MERRIMACK STREET BUILDING 9   SE DECISION MADE: 27-JUL-12
LAWRENCE MA 01843                 510(k) STATEMENT

DEVICE: ZEOBI
IVIVI HEALTH SCIENCE, LLC         510(k) NO: K121338(SPECIAL)
ATTN: KATHRYN  CLUBB              PHONE NO : 415 814 2460   
330 TOWNSEND STREET SUITE 100     SE DECISION MADE: 27-JUL-12
SAN FRANCISCO CA 94107            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL
ACCESS SCIENTIFIC, INC.           510(k) NO: K121748(SPECIAL)
ATTN: ALBERT  MISAJON             PHONE NO : 858 259 8333   
12526 HIGH BLUFF DRIVE SUITE 360  SE DECISION MADE: 27-JUL-12
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES
CARDINAL HEALTH, INC.             510(k) NO: K121897(SPECIAL)
ATTN: TATYANA  BOGDAN             PHONE NO : 847 887 2325   
1430  WAUKEGAN ROAD               SE DECISION MADE: 27-JUL-12
MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XPRESSWAY RX CATHETER (6F LD-VERISON)
KANEKA PHARMA AMERICA LLC         510(k) NO: K121301(SPECIAL)
ATTN: JOSEPH  DEPAOLO             PHONE NO : 603 880 1433   
546 FIFTH AVE., 21ST FLOOR        SE DECISION MADE: 30-JUL-12
New York NY 10036                 510(k) STATEMENT

DEVICE: KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT
KEVO MEDICAL SUPPLIES             510(k) NO: K113199(TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 888 729 9674   
1468 HARWELL AVE.                 SE DECISION MADE: 30-JUL-12
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM
SPINAL ELEMENTS, INC.             510(k) NO: K120467(TRADITIONAL)
ATTN: BENJAMIN A KIMBALL          PHONE NO : 760 607 1816   
2744 LOKER AVE. W. SUITE 100      SE DECISION MADE: 30-JUL-12
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST
IND NDIAGNOSTIC INC.              510(k) NO: K121231(TRADITIONAL)
ATTN: KAI  LOU                    PHONE NO : 604 522 1619
1629 FOSTERS WAY                  SE DECISION MADE: 30-JUL-12
DELTA, BRITISH COLUMBIA    CA V3M 510(k) STATEMENT

DEVICE: DYNASTY BIOFOAM SHELL
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K121544(TRADITIONAL)
ATTN: YUAN  LI                    PHONE NO : 901 867 4146   
5677 AIRLINE RD.                  SE DECISION MADE: 30-JUL-12
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENTINEL
C-RAD POSITIONING AB              510(k) NO: K120668(TRADITIONAL)
ATTN: JANINA  OSTLING             PHONE NO : 461 866 6930
BREDGRAND 18                      SE DECISION MADE: 30-JUL-12
UPPSALA    SW 75320               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYNAPBV BODY SOFTWARE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K121292(TRADITIONAL)
ATTN: PATRICIA D JONES            PHONE NO : 610 448 3536   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 30-JUL-12
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLATO MICROCATH 27 MICROCATHETER
SCIENTIA VASCULAR , LLC           510(k) NO: K121734(TRADITIONAL)
ATTN: SHARON  ROCKWELL            PHONE NO : 714 695 9269   
2700 SOUTH 900 WEST SUITE D       SE DECISION MADE: 30-JUL-12
SALT LAKE CITY UT 84119           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM
LETO ENTERPRISE LTD.              510(k) NO: K120511(TRADITIONAL)
ATTN: SABRINA  WEI                PHONE NO : 867 558 3089699
308 HENNESSY RD                   SE DECISION MADE: 30-JUL-12
WANCHAI    HK HONGKONG            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD
SAFE ORTHOPAEDICS                 510(k) NO: K121299(TRADITIONAL)
ATTN: PIERRE  DUMOUCHEL           PHONE NO : 330 134 215000
Parc des Bellevues Allee R.LuxemboSE DECISION MADE: 30-JUL-12
Eragny sur Oise    FR 95610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HIP SYSTEMS
HOWMEDICA OSTEONICS CORP          510(k) NO: K121308(TRADITIONAL)
ATTN: KAREN  ARIEMMA              PHONE NO : 201 831 5718   
325 CORPORATE DR.                 SE DECISION MADE: 30-JUL-12
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STENTUBE LACRIMAL INTUBATION SET
QUEST MEDICAL, INC.               510(k) NO: K113118(SPECIAL)
ATTN: AMY  CLENDENING-WHEELER     PHONE NO : 972 332 6338   
ONE ALLENTOWN PKWY.               SE DECISION MADE: 31-JUL-12
ALLEN TX 75002                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSSEOSPEED PLUS
ASTRA TECH AB                     510(k) NO: K120414(TRADITIONAL)
ATTN: LINDA K SCHULZ              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL, SUITE 200   SE DECISION MADE: 31-JUL-12
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HQS INTRODUCER
ALSEAL                            510(k) NO: K113849(TRADITIONAL)
ATTN: JEAN-FRANCOIS  DELFORGE     PHONE NO : 330 381 616993
ESPACE VALENTIN- VALPARC 6C, RUE DSE DECISION MADE: 31-JUL-12
BESANCON    FR 25048              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM
INOVA DIAGNOSTICS, INC.           510(k) NO: K112545(TRADITIONAL)
ATTN: MICHAEL  MAHLER             PHONE NO : 858 586 9900   
9900 OLD GROVE RD.                SE DECISION MADE: 31-JUL-12
SAN DIEGO CA 92131 1638           510(k) STATEMENT

DEVICE: DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT
NOVOCOL, INC.                     510(k) NO: K120283(ABBREVIATED)
ATTN: CORA  BRACHO-TROSONIS       PHONE NO : 303 665 7535   
416 SOUTH TAYLOR AVE.             SE DECISION MADE: 31-JUL-12
LOUISVILLE CO 80027               510(k) STATEMENT

DEVICE: VIDAS D-DIMER EXCLUSION II (DEX2)
BIOMERIEUX, INC.                  510(k) NO: K112818(TRADITIONAL)
ATTN: VERONICA  DAENZER           PHONE NO : 314 731 8573   
595 ANGLUM RD.                    SE DECISION MADE: 31-JUL-12
HAZELWOOD MO 63042                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VICTUS LASER PLATFORM
TECHNOLAS PERFECT VISION GMBH     510(k) NO: K120426(TRADITIONAL)
ATTN: KEN  NEHMER                 PHONE NO : 415 297 0408   
1025 SANCHEZ STREET               SE DECISION MADE: 31-JUL-12
SAN FRANCISCO CA 94114            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAZYME HOMOCYSTEINE POC TEST KIT
DIAZYME LABORATORIES              510(k) NO: K121053(TRADITIONAL)
ATTN: ABHIJIT  DATTA              PHONE NO : 858 455 4762   
12889 GREGG COURT                 SE DECISION MADE: 31-JUL-12
POWAY CA 92064                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATOM 1 (MODEL: BRC 2200)
BIOELECTRIC RESEARCH CORPORATION  510(k) NO: K121578(TRADITIONAL)
ATTN: STEVEN  KAYE                PHONE NO : 775 884 1200   
112 N. CURRY STREET               SE DECISION MADE: 31-JUL-12
CARSON CITY NV 89703              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SYNTHES MATRIX SYSTEM
SYNTHES SPINE                     510(k) NO: K120838(TRADITIONAL)
ATTN: HEATHER  GUERIN             PHONE NO : 610 719 5432   
1302 WRIGHTS LANE EAST            SE DECISION MADE: 31-JUL-12
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   267                                     
                                                 TOTAL WITH SUMMARIES        247                                     
                                                 TOTAL WITH STATEMENTS        20