• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

September 2011 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD September 2011


DEVICE: MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG
MEDIPURPOSE PTE. LTD.             510(k) NO: K110062(TRADITIONAL)
ATTN: JULIE  STEPHENS             PHONE NO : 678 513 0693   
111 LAUREL RIDGE DRIVE            SE DECISION MADE: 01-SEP-11
ALPHARETTA GA 30004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE
BIOMET 3I, INC.                   510(k) NO: K110565(TRADITIONAL)
ATTN: JOSE E CABRERA              PHONE NO : 561 776 6840   
4555 RIVERSIDE DR.                SE DECISION MADE: 01-SEP-11
PALM BEACH GARDENS FL 33410       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLY-CHEM 90 TOTAL BILIRUBIN
POLYMEDCO, INC.                   510(k) NO: K111143(TRADITIONAL)
ATTN: HELEN  LANDICHO             PHONE NO : 206 402 6146   
510 FURNACE DOCK RD.              SE DECISION MADE: 01-SEP-11
CORTLANDT MANOR NY 10567          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
FUJIFILM MEDICAL SYSTEMS, USA INC.510(k) NO: K110729(TRADITIONAL)
ATTN: PETER  ALTMAN               PHONE NO : 203 602 3576   
419 WEST AVENUE                   SE DECISION MADE: 01-SEP-11
STAMFORD CT 06902                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
WANGDA PLASTIC CO., LTD           510(k) NO: K110944(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
RM 1606 BLDG 1, JIANXIANG YUAN NO SE DECISION MADE: 01-SEP-11
HAIDIAN DISTRICT, BEIJING    CH 10510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES
STERIS CORPORATION                510(k) NO: K103331(TRADITIONAL)
ATTN: ROBERT F SULLIVAN           PHONE NO : 440 392 7695   
5960 HEISLEY ROAD                 SE DECISION MADE: 01-SEP-11
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROMA (HE4 EIA + ARCHITECT CA 125 II)
FUJIREBIO DIAGNOSTICS, INC.       510(k) NO: K103358(TRADITIONAL)
ATTN: DIANA L DICKSON             PHONE NO : 610 240 3917   
201 GREAT VALLEY PKWY.            SE DECISION MADE: 01-SEP-11
MALVERN PA 19355 1307             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)
GYRUS ACMI, INC.                  510(k) NO: K111059(TRADITIONAL)
ATTN: LORRAINE  CALZETTA          PHONE NO : 508 804 2752   
136 TURNPIKE RD.                  SE DECISION MADE: 01-SEP-11
SOUTHBOROUGH MA 01772             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAPPHIRE NC
ORBUSNEICH MEDICAL, INC.          510(k) NO: K103808(TRADITIONAL)
ATTN: JOHN  PAZIENZA              PHONE NO : 954 730 0711   
5363 N.W. 35TH AVE.               SE DECISION MADE: 01-SEP-11
FT. LAUDERDALE FL 33309 6315      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR
COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K112349(SPECIAL)
ATTN: ANGELA V ARSDALE            PHONE NO : 203 492 5496   
60 Middletown Ave                 SE DECISION MADE: 01-SEP-11
North Haven CT 06473              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMG SUCTION UNIT
EMG TECHNOLOGY CO., LTD.          510(k) NO: K112421(TRADITIONAL)
ATTN: PAUL  CHO                   PHONE NO : 886 423 596033
NO.58, 35 RD, TAICHUNG INDUSTRIAL SE DECISION MADE: 01-SEP-11
TAICHUNG    TW 40768              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ALP 501 RB PUMP SYSTEM
CURRIE MEDICAL SPECIALTIES, INC.  510(k) NO: K112311(SPECIAL)
ATTN: BERNICE  NAVARRO            PHONE NO : 626 303 3521   
730 EAST LOS ANGELES AVE.         SE DECISION MADE: 01-SEP-11
MONROVIA CA 91016                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
LUMINEX MOLECULAR DIAGNOSTICS, INC510(k) NO: K112199(SPECIAL)
ATTN: LUBNA  SYED                 PHONE NO : 416 593 4323
439 UNIVERSITY AVE. SUITE 900     SE DECISION MADE: 01-SEP-11
TORONTO, ONTARIO    CA M5G 1Y8    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM
GE HEALTHCARE                     510(k) NO: K112213(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 W. INNOVATION DRIVE          SE DECISION MADE: 01-SEP-11
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORA G20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K101631(TRADITIONAL)
ATTN: TELING  HSU                 PHONE NO : 866 266 258188
3F, 5F, NO 127 WUGONG 2ND RD WUGU SE DECISION MADE: 02-SEP-11
TAIPEI COUNTY    TW 24888         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GEM-TONE BODY TRAINING SYSTEM
GEMORE TECHNOLOGY CO., LTD.       510(k) NO: K102933(TRADITIONAL)
ATTN: BODEN S LAI                 PHONE NO : 886 288 091799
11 FL, NO. 29-5, SEC. 2 CHUNG CHENSE DECISION MADE: 02-SEP-11
TAN SHUI, TAIPEI HSIEN    TW 251  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION
ZIMMER, INC.                      510(k) NO: K110791(TRADITIONAL)
ATTN: ANTHONY  FRANCALANCIA       PHONE NO : 574 372 4570   
P.O. BOX 708                      SE DECISION MADE: 02-SEP-11
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMP A-I-R
OMRON HEALTHCARE, INC.            510(k) NO: K110860(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 02-SEP-11
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROSIM 4, PROSIM 6, PROSIM 8
FLUKE BIOMEDICAL                  510(k) NO: K110429(TRADITIONAL)
ATTN: JOHN  NELSON                PHONE NO : 440 498 2579   
6045 COCHRAN RD.                  SE DECISION MADE: 02-SEP-11
SOLON OH 44139                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U
ANSELL HEALTHCARE PRODUCTS, INC.  510(k) NO: K111139(TRADITIONAL)
ATTN: NEIL  BURRIS                PHONE NO : 303 223 4336   
555 ZANG STREET SUITE 100         SE DECISION MADE: 02-SEP-11
LAKEWOOD CO 80228                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IP TEMP CEMENT
SHOFU DENTAL CORPORATION          510(k) NO: K111685(TRADITIONAL)
ATTN: DAVID P MORAIS              PHONE NO : 760 736 3277   
1225 STONE DRIVE                  SE DECISION MADE: 02-SEP-11
SAN MARCOS CA 92078               510(k) STATEMENT

DEVICE: AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS
STERIS CORPORATION                510(k) NO: K111810(SPECIAL)
ATTN: ROBERT  SULLIVAN            PHONE NO : 440 354 2600   
5960 HEISLEY ROAD                 SE DECISION MADE: 02-SEP-11
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROSUTURE ANCHORS
ARTHREX, INC.                     510(k) NO: K112237(SPECIAL)
ATTN: COURTNEY  SMITH             PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 02-SEP-11
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL RADIOGRAPHY
CANON, INC.-MEDICAL EQUIPMENT GROU510(k) NO: K111682(SPECIAL)
ATTN: KOJI  KUBO                  PHONE NO : 81 425 481253
C/O COSMOS CORPORATION 3F 2-17-6 ASE DECISION MADE: 02-SEP-11
TACHIKAWA-SHI, TOKYO    JA 190-001510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL RADIOGRAPHY
CANON, INC.-MEDICAL EQUIPMENT GROU510(k) NO: K112309(SPECIAL)
ATTN: KOJI  KUBO                  PHONE NO : 814 254 81253
3F 2-17-6 AKEBONO-CHO             SE DECISION MADE: 02-SEP-11
TACHIKAWA-SHI, TOKYO    JA 190-001510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NM-7000
NUGA MEDICAL CO., LTD             510(k) NO: K111329(TRADITIONAL)
ATTN: CHARLIE  MACK               PHONE NO : 541 376 5063   
77325 JOYCE WAY                   SE DECISION MADE: 06-SEP-11
ECHO OR 97826                     510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: FULL CORE BIOPSY SYSTEM
PROMEX TECHNOLOGIES, LLC          510(k) NO: K111765(TRADITIONAL)
ATTN: ALLISON  SCOTT              PHONE NO : 317 569 9500   
9001 WESLEYAN ROAD                SE DECISION MADE: 06-SEP-11
INDIANAPOLIS IN 46268             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XTRA
SORIN GROUP ITALIA S.R.L          510(k) NO: K112245(SPECIAL)
ATTN: BARRY  SALL                 PHONE NO : 781 434 4742   
PAREXEL CONSULTING 195 WEST STREETSE DECISION MADE: 06-SEP-11
WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERALAS 980NM DIODE LASER FAMILY
BIOLITEC MEDICAL DEVICES, INC     510(k) NO: K112324(TRADITIONAL)
ATTN: HARRY  HAYES                PHONE NO : 413 250 0779   
1349 MAIN ROAD                    SE DECISION MADE: 06-SEP-11
GRANDVILLE MA 01034               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...
IMMUNODIAGNOSTIC SYSTEMS LTD.     510(k) NO: K111650(ABBREVIATED)
ATTN: MICK  FENTON                PHONE NO : 440 191 5190660
10 DIDCOT WAY, BOLDEN BUSINESS PARSE DECISION MADE: 06-SEP-11
BOLDON, TYNE & WEAR    UK NE35 9PD510(k) STATEMENT

DEVICE: HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON
TGM MEDICAL                       510(k) NO: K111472(TRADITIONAL)
ATTN: DENNIS H CRANE              PHONE NO : 952 374 6012   
5145 GOLDEN FOOTHILL PARKWAY SUITESE DECISION MADE: 06-SEP-11
EL DORADO CA 95762                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MYSAFETY SYRINGE
MEDICALCHAIN INTL. CORP.          510(k) NO: K111734(SPECIAL)
ATTN: ROBIN  HWANG                PHONE NO : 805 376 0372   
1808 SEABREEZE COUNT,             SE DECISION MADE: 06-SEP-11
THOUSAND OAKS CA 91320            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM
CILAG GMBH INTERNATIONAL          510(k) NO: K110637(TRADITIONAL)
ATTN: FIONA  LEEPER               PHONE NO : 440 146 3721596
LANDIS AND GYR STRASSE 1          SE DECISION MADE: 07-SEP-11
ZUG    SZ 6300                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORELEADER HEMO-PAD MODEL CPII 02030
CORELEADER BIOTECH CO., LTD.      510(k) NO: K102944(TRADITIONAL)
ATTN: IAN  LI                     PHONE NO : 886 226 968880
19F NO. 100, SEC 1 SINTAI 5TH RD, SE DECISION MADE: 07-SEP-11
TAIPEI, TAIWAN    TW 22102        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EVADYNE TEMPORARY CROWN AND BRIDGE RESIN
NEO DENTAL CHEMICAL PRODUCTS CO., 510(k) NO: K111666(TRADITIONAL)
ATTN: ROBERT  SEIPLE              PHONE NO : 512 327 9997   
611 WEST 5TH STREET               SE DECISION MADE: 07-SEP-11
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PILOT SPINAL SYSTEM
LIFE SPINE, INC                   510(k) NO: K111729(SPECIAL)
ATTN: RANDY  LEWIS                PHONE NO : 847 884 6117   
2401 W. HASSELL RD SUITE 1535     SE DECISION MADE: 07-SEP-11
HOFFMAN ESTATES IL 60169          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPAL BAND CEMENT
ULTRADENT PRODUCTS, INC.          510(k) NO: K111696(TRADITIONAL)
ATTN: DIANE  ROGERS               PHONE NO : 801 553 4491   
505 WEST 10200 SOUTH              SE DECISION MADE: 07-SEP-11
SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNITE BIOMATRIX
SYNOVIS ORTHOPEDIC & WOUNDCARE    510(k) NO: K112399(SPECIAL)
ATTN: AMY  BOUCLY                 PHONE NO : 949 502 3240   
6 Jenner, Suite 150               SE DECISION MADE: 07-SEP-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
EPS BIO TECHNOLOGY CORP.          510(k) NO: K112272(SPECIAL)
ATTN: YC  LEI                     PHONE NO : 886 366 86868
NO.8 R&D RD III HSINCHU SCIENCE PASE DECISION MADE: 07-SEP-11
HSINCHU CITY, HSINCHU    TW 30077 510(k) STATEMENT

DEVICE: A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
SPINEWORKS, LLC                   510(k) NO: K111166(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD.                SE DECISION MADE: 08-SEP-11
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROLINK ADHESIVES (PROLINK, PROLINK SE)
SILMET LTD.                       510(k) NO: K110403(TRADITIONAL)
ATTN: MOSHE  ZALSMAN              PHONE NO : 972 373 53000
12 HASSADNA ST.                   SE DECISION MADE: 08-SEP-11
OR YEHUDA    IS 60200             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD
ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K103615(TRADITIONAL)
ATTN: HYMAN  KATZ                 PHONE NO : 973 852 0158   
4 HENDERSON DRIVE                 SE DECISION MADE: 08-SEP-11
WEST CALDWELL NJ 07006            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS
POLYMEDCO, INC.                   510(k) NO: K110818(TRADITIONAL)
ATTN: HELEN  LANDICHO             PHONE NO : 206 402 6146   
510 FURNACE DOCK RD.              SE DECISION MADE: 08-SEP-11
CORTLANDT MANOR NY 10567          510(k) STATEMENT

DEVICE: FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI
OCULUS PRIVATE LIMITED            510(k) NO: K103132(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
5401 S COTTONWOOD CT.             SE DECISION MADE: 08-SEP-11
GREENWOOD VILLAGE CO 80121        510(k) STATEMENT

DEVICE: SV BRAIN ARRAY, SIEMENS 3T
MRI INTERVENTIONS, INC.           510(k) NO: K111802(TRADITIONAL)
ATTN: E.F.  WADDELL               PHONE NO : 949 900 6833   
5 Musick                          SE DECISION MADE: 08-SEP-11
Irvine CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RTVUE CAM WITH CORNEAL POWER UPGRADE
OPTOVUE, INC.                     510(k) NO: K111505(TRADITIONAL)
ATTN: JOHN  TALARICO              PHONE NO : 510 623 8868   
45531 NORTHPORT LOOP W.           SE DECISION MADE: 08-SEP-11
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDLINE VIAL DECANTER
MEDLINE INDUSTRIES, INC.          510(k) NO: K111577(TRADITIONAL)
ATTN: MATT  CLAUSEN               PHONE NO : 847 643 4785   
ONE MEDLINE PLACE                 SE DECISION MADE: 08-SEP-11
MUNDELEIN IL 60060                510(k) STATEMENT

DEVICE: XELIS FUSION
INFINITT CO., LTD.                510(k) NO: K111613(TRADITIONAL)
ATTN: CARL  ALLETTO               PHONE NO : 469 684 1980   
1600 MANCHESTER WAY               SE DECISION MADE: 08-SEP-11
CORINTH TX 76210                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WONDFO METHADONE URINE TEST,OPIATE TEST
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K112310(TRADITIONAL)
ATTN: JOE  SHIA                   PHONE NO : 240 505 7880   
504 EAST DIAMOND AVE. SUITE F     SE DECISION MADE: 08-SEP-11
GAITHERSBURG MD 20878             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMNI PATIENT MONITOR
INFINIUM MEDICAL                  510(k) NO: K112329(SPECIAL)
ATTN: JOHN  O'BRIEN               PHONE NO : 813 645 2855   
962 ALLEGRO LN.                   SE DECISION MADE: 08-SEP-11
APOLLO BEACH FL 33572             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PREFILLED CATHETER INFLATION SYRINGE
AVAIL MEDICAL PRODUCTS, INC.      510(k) NO: K112209(SPECIAL)
ATTN: STEVEN A HOWELL             PHONE NO : 858 457 1988   
5950 NANCY RIDGE ROAD SUITE 500   SE DECISION MADE: 08-SEP-11
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIXATE TISSUE BAND
ANULEX TECHNOLOGIES, INC          510(k) NO: K111462(TRADITIONAL)
ATTN: RACHEL  KENNEDY             PHONE NO : 952 224 4000   
5600 ROWLAND ROAD, STE 280        SE DECISION MADE: 08-SEP-11
MINNETONKA MN 55343               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
COLOPLAST CORP.                   510(k) NO: K112386(SPECIAL)
ATTN: TIM  CRABTREE               PHONE NO : 612 302 4922   
1601 WEST RIVER N                 SE DECISION MADE: 08-SEP-11
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GE VEO RECONSTRUCTION OPTION
GENERAL ELECTRIC CO.              510(k) NO: K103489(TRADITIONAL)
ATTN: ANDREW J MENDEN             PHONE NO : 262 312 7068   
3000 N. GRANDVIEW BLVD. W1140     SE DECISION MADE: 09-SEP-11
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRYOPEN CRYOSURGICAL SYSTEM, K102214
CRYOPEN, INC.                     510(k) NO: K110754(TRADITIONAL)
ATTN: MIKE  HAAS, M.D.            PHONE NO : 877 246 3955   
577 COMMERCE ST SUITE B           SE DECISION MADE: 09-SEP-11
SOUTHLAKE TX 76092                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IFS PROFILE PLATES, SCREWS, AND WASHERS
INTERNAL FIXATION SYSTEMS, INC.   510(k) NO: K110086(TRADITIONAL)
ATTN: CHRIS  ENDARA               PHONE NO : 305 884 5993   
10100 N.W. 116TH WAY, STE. 18     SE DECISION MADE: 09-SEP-11
MIAMI FL 33178                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MRGFUS PELVIC PA COIL MODEL 1.0
INSIGHTECH, LTD                   510(k) NO: K111060(SPECIAL)
ATTN: ORI  LUBIN                  PHONE NO : 972 544 881399
5 NAHUM HETH ST.                  SE DECISION MADE: 09-SEP-11
TIRAT CARMEL    IS 39120          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
DATEX-OHMEDA                      510(k) NO: K111116(TRADITIONAL)
ATTN: MONICA  MORRISON            PHONE NO : 608 221 1551   
PO BOX 7550 3030 OHMEDA DR        SE DECISION MADE: 09-SEP-11
MADISON WI 53707                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING
SALIENT SURGICAL TECHNOLOGIES, INC510(k) NO: K111285(TRADITIONAL)
ATTN: RITA M CALNAN               PHONE NO : 603 842 6313   
180 INTERNATIONAL DRIVE           SE DECISION MADE: 09-SEP-11
Portsmouth NH 03801               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOTEQ ANGIOGRAPHIC CATHETER
BIOTEQUE CORP.                    510(k) NO: K102633(TRADITIONAL)
ATTN: JENNIFER  REICH             PHONE NO : 928 863 8140   
2904 N BOLDT DRIVE                SE DECISION MADE: 09-SEP-11
FLAGSTAFF AZ 86001                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE
ASAHI INTECC CO., LTD.            510(k) NO: K101986(SPECIAL)
ATTN: YOSHI  TERAI                PHONE NO : 949 756 8252   
2500 RED HILL SUITE 210           SE DECISION MADE: 09-SEP-11
SANTA ANA, CA 92705               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX
AVINGER, INC.                     510(k) NO: K111704(TRADITIONAL)
ATTN: SEVRINA  CIUCCI, RAC        PHONE NO : 408 316 4837   
400 CHESAPEAKE DRIVE              SE DECISION MADE: 09-SEP-11
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIMAX ANTI-FOG SOLUTION
UNIMAX MEDICAL SYSTEMS, INC.      510(k) NO: K111622(TRADITIONAL)
ATTN: MICHAEL  LEE                PHONE NO : 886 228 096995
NO. 45, MINSHEN RD. DANSHUI TOWN  SE DECISION MADE: 09-SEP-11
TAIPEI COUNTY    TW 251           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOSKELETON(R) TAS
TITAN SPINE, LLC                  510(k) NO: K111626(TRADITIONAL)
ATTN: RICH  JANSEN                PHONE NO : 612 281 5505   
13540 GUILD AVE                   SE DECISION MADE: 09-SEP-11
APPLE VALLEY MN 55124             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW RJ CONSTRAINED LINERS
SMITH & NEPHEW, INC.              510(k) NO: K111635(TRADITIONAL)
ATTN: MEGAN  BEVILL               PHONE NO : 901 399 5340   
1450 BROOKS RD.                   SE DECISION MADE: 09-SEP-11
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOSHIBA 3T EXTRA LARGE KNEE COIL
QUALITY ELECTRODYNAMICS           510(k) NO: K112313(SPECIAL)
ATTN: CHRISTIE  ZYDYK             PHONE NO : 440 484 2228   
700 BETA DR. SUITE 100            SE DECISION MADE: 09-SEP-11
MAYFIELD VILLAGE OH 44143         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLOSUREFAST RADIOFREQUENCY CATHETER
COVIDIEN                          510(k) NO: K111887(SPECIAL)
ATTN: DANIEL  CAMPION             PHONE NO : 508 452 4135   
15 HAMPSHIRE STREET               SE DECISION MADE: 09-SEP-11
MANSFIELD MA 02048                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES
CARDIAC ASSIST, MAQUET CARDIOVASCU510(k) NO: K112327(SPECIAL)
ATTN: HELDER A SOUSA              PHONE NO : 201 995 8710   
1300 Macarthur Blvd               SE DECISION MADE: 09-SEP-11
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K112395(TRADITIONAL)
ATTN: JOE  SHIA                   PHONE NO : 240 505 7880   
504 EAST DIAMOND AVE SUITE F      SE DECISION MADE: 09-SEP-11
GAITHERSBURG MD 20878             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESOLUTIONMD MOBILE MODEL RMB-MOB-2X
CALGARY SCIENTIFIC, INC.          510(k) NO: K111346(TRADITIONAL)
ATTN: KYLE  PETERSON              PHONE NO : 403 76 77945
SUITE 208, 1210 20TH AVENUE SE    SE DECISION MADE: 09-SEP-11
CALGARY, ALBERTA    CA T2G 1M8    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: .DECIMAL ELECTRON APERTURE
.DECIMAL, INC.                    510(k) NO: K111759(TRADITIONAL)
ATTN: DANIEL L BENNETT            PHONE NO : 407 330 3300   
121 CENTRAL PARK PLACE            SE DECISION MADE: 09-SEP-11
SANFORD FL 32771                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WATERPAP VALVE
AIRWAYS DEVELOPMENT, LLC          510(k) NO: K110713(TRADITIONAL)
ATTN: RICHARD J LARKIN            PHONE NO : 973 889 3611   
P.O. BOX 558                      SE DECISION MADE: 12-SEP-11
CEDAR KNOLLS NJ 07927             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JUELL HARD CURE
JUELL DENTAL                      510(k) NO: K111177(TRADITIONAL)
ATTN: ANGELA  BLACKWELL           PHONE NO : 704 450 9934   
2401 N COMMERCE                   SE DECISION MADE: 12-SEP-11
ARDMORE OK 73401                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JUELL SOFT CURE
JUELL DENTAL                      510(k) NO: K111178(TRADITIONAL)
ATTN: ANGELA  BLACKWELL           PHONE NO : 704 450 9934   
2401 N COMMERCE                   SE DECISION MADE: 12-SEP-11
ARDMORE OK 73401                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRAUMANN TIBRUSH
STRAUMANN USA                     510(k) NO: K111724(TRADITIONAL)
ATTN: ELAINE  ALAN                PHONE NO : 978 747 2513   
60 MINUTEMAN ROAD                 SE DECISION MADE: 12-SEP-11
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISCOVERY
INTUITIVE SPINE, LLC              510(k) NO: K111484(TRADITIONAL)
ATTN: JENNIFER  PALINCHIK         PHONE NO : 440 933 8850   
33490 PIN OAK PARKWAY             SE DECISION MADE: 12-SEP-11
AVON LAKE OH 44012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REKA E100
REKA PTE LTD                      510(k) NO: K111438(ABBREVIATED)
ATTN: LARRY  PETERSEN             PHONE NO : 303 489 2500   
1001 BEAR ISLAND ROAD SUITE 136   SE DECISION MADE: 12-SEP-11
SUMMERVILLE SC 29483              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMARTSHEARS
NUSCIENCE CONSULTING AND MANAGEMEN510(k) NO: K112400(TRADITIONAL)
ATTN: NIKOLE  GOLDSMITH           PHONE NO : 904 537 9595   
P.O. BOX  8507                    SE DECISION MADE: 12-SEP-11
FLEMING ISLAND FL 32006           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA..
CENDRES & METAUX SA               510(k) NO: K111390(SPECIAL)
ATTN: TANJA  BONGNI               PHONE NO : 41 58 3602302
RUE DE BOUJEAN 122                SE DECISION MADE: 12-SEP-11
BIEL/BIENNE    SZ 2501            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104
SUNSET HEALTHCARE SOLUTIONS, LLC  510(k) NO: K102483(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 952 5412   
5401 S. COTTONWOOD CT.            SE DECISION MADE: 13-SEP-11
GREENWOOD VILLAGE CO 80121        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLGATE DESENSITIZING DENTAL CREAM
COLGATE-PALMOLIVE CO.             510(k) NO: K103461(TRADITIONAL)
ATTN: CHARLES P IRELAND           PHONE NO : 732 878 7500   
909 RIVER RD.                     SE DECISION MADE: 13-SEP-11
PISCATAWAY NJ 08855 1343          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER
LEMAITRE VASCULAR INC.            510(k) NO: K110891(TRADITIONAL)
ATTN: ANDREW  HODGKINSON          PHONE NO : 781 221 2266   
63 SECOND AVENUE                  SE DECISION MADE: 13-SEP-11
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
ZHAOYANG PLASTIC CO., LTD         510(k) NO: K110945(TRADITIONAL)
ATTN: CHU  ZIAOAN                 PHONE NO : 861 082 387441
RM 1606 BLDG 1, JIANXIANG YUAN NO SE DECISION MADE: 13-SEP-11
HAIDIAN DISTRICT, BEIJING    CH 10510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REUSABLE STIMULATING ELECTRODES
ADVENA LTD                        510(k) NO: K111270(TRADITIONAL)
ATTN: JUDY  BURTON                PHONE NO : 972 243 5105   
3010 LBJ FRWY 12TH FLOOR          SE DECISION MADE: 13-SEP-11
DALLAS TX 75234                   510(k) STATEMENT

DEVICE: EPISIL
CAMURUS AB                        510(k) NO: K101769(TRADITIONAL)
ATTN: MAUREEN  O'CONNELL          PHONE NO : 978 207 1245   
5 TIMBER LANE                     SE DECISION MADE: 13-SEP-11
NORTH READING MA 01864            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION
ALMA LASERS, INC.                 510(k) NO: K112031(SPECIAL)
ATTN: ANNE  WORDEN                PHONE NO : 925 895 1200   
485 HALF DAY RD. SUITE NO. 100    SE DECISION MADE: 13-SEP-11
BUFFALO GROVE IL 60089            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XELIS CARDIAC
INFINITT CO., LTD.                510(k) NO: K111660(TRADITIONAL)
ATTN: CARL  ALLETTO               PHONE NO : 469 684 1980   
1600 MANCHESTER WAY               SE DECISION MADE: 13-SEP-11
CORINTH TX 76521                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHEAUMANN PL-1064
SHEAUMANN LASERS                  510(k) NO: K111359(TRADITIONAL)
ATTN: TIMOTHY J SHEA              PHONE NO : 407 590 2050   
189 WINDING OAKS LANE             SE DECISION MADE: 13-SEP-11
OVIEDO FL 32765                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMCOM COMMTECH MESSENGER
AMCOM SOFTWARE,INC.               510(k) NO: K112047(TRADITIONAL)
ATTN: THOMAS  KROENKE             PHONE NO : 303 956 4232   
PO BOX 3018                       SE DECISION MADE: 13-SEP-11
NEDERLAND CO 80466                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDICAL CONCEPTS INTERBODY FUSION SYSTEM
MEDICAL CONCEPTS, INC.            510(k) NO: K110659(TRADITIONAL)
ATTN: CHRISTOPHER  CANIS          PHONE NO : 512 626 9599   
11467 HUEBNER RD SUITE #350       SE DECISION MADE: 13-SEP-11
SAN ANTONIO TX 78230              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM
QUALIREG RESOURCES LLC            510(k) NO: K111115(SPECIAL)
ATTN: JOHN  SANDERS               PHONE NO : 954 993 5581   
2361 NW 105TH LANE                SE DECISION MADE: 13-SEP-11
SUNRISE FL 33322                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JBAIDS INFLUENZA A SUBTYPING KIT
U.S. ARMY MEDICAL MATERIEL DEVELOP510(k) NO: K111778(TRADITIONAL)
ATTN: PATRICIA M BEVERLY          PHONE NO : 301 619 2980   
1430 VETERANS DRIVE               SE DECISION MADE: 13-SEP-11
FORT DETRICK MD 21702             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JBAIDS INFLUENZA A&B DETECTION KIT
U.S. ARMY MEDICAL MATERIAL DEVELOP510(k) NO: K111775(TRADITIONAL)
ATTN: PATRICIA  BEVERLY           PHONE NO : 301 619 2980   
1430 VETERANS DRIVE               SE DECISION MADE: 13-SEP-11
FORT DETRICK MD 21702             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LITE PELVIC FLOOR REPAIR KITS
BOSTON SCIENTIFIC CORP.           510(k) NO: K103426(ABBREVIATED)
ATTN: MICHELLE  BERRY             PHONE NO : 508 683 4941   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 14-SEP-11
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLLAGEN POWDER
INNOCOLL PHARMACEUTICALS LTD      510(k) NO: K103648(TRADITIONAL)
ATTN: AARON  WYSE                 PHONE NO : 353 090 6666091
MIDLANDS RESEARCH AND INNOVATION CSE DECISION MADE: 14-SEP-11
ATHLONE, CO. WESTMEATH    EI EI   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KJ SUBMERGED SYSTEM
KJ MEDITECH CO., LTD              510(k) NO: K103810(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 869 3080   
951 STARBUCK ST. UNIT J           SE DECISION MADE: 14-SEP-11
FULLERTON CA 92833                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FOB ONE STEP RAPID TEST
ORIENT GENE BIOTECH               510(k) NO: K110309(TRADITIONAL)
ATTN: GARY  LEHNUS                PHONE NO : 570 620 0198   
150 CHERRY LANE RD                SE DECISION MADE: 14-SEP-11
EAST STROUDSBURG PA 18301         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD
CHEMTRON BIOTECH, INC.            510(k) NO: K111322(TRADITIONAL)
ATTN: JANE  ZHANG                 PHONE NO : 858 530 2868   
8370 JUNIPER CREEK LANE SUITE 1-2 SE DECISION MADE: 14-SEP-11
SAN DIEGO CA 92126                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITAL SIGNS MONITOR
ADVANCED INSTRUMENTS, INC.        510(k) NO: K112465(TRADITIONAL)
ATTN: JORGE  MILLAN               PHONE NO : 305 925 1260   
601 WEST 20 ST                    SE DECISION MADE: 14-SEP-11
HIALEAH FL 33010                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS MYOGLOBIN CALCHECK 5
ROCHE DIAGNOSTICS                 510(k) NO: K112113(TRADITIONAL)
ATTN: KELLY COLLEEN  O'MAINE ADAMSPHONE NO : 317 521 3577   
9115 HAGUE ROAD                   SE DECISION MADE: 14-SEP-11
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PADLOCK
RELIANCE ORTHODONTIC PRODUCTS, INC510(k) NO: K111814(SPECIAL)
ATTN: PAULA  WENDLAND             PHONE NO : 630 773 4009   
1540 WEST THORNDALE AVE.          SE DECISION MADE: 14-SEP-11
ITASCA IL 60143                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K112198(SPECIAL)
ATTN: ASHLEY  PYLE                PHONE NO : 508 683 4359   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 14-SEP-11
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL RETINAL CAMERA
CANON, INC.                       510(k) NO: K111612(SPECIAL)
ATTN: KOJI  KUBO                  PHONE NO : 814 254 81253
TOKYO OFFICE 6-5-3 BEAUNE HONKOMAGSE DECISION MADE: 14-SEP-11
HONKOMAGOME, BUNKYO-KU TOKYO    JA510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OCTOTMPORT
DALIM SURGNET CORPORATION         510(k) NO: K112196(SPECIAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114   
325 N PUENTE ST. UNIT B           SE DECISION MADE: 14-SEP-11
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHEAUMANN PL-980
SHEAUMANN LASERS                  510(k) NO: K111360(TRADITIONAL)
ATTN: TIMOTHY J SHEA              PHONE NO : 407 590 2050   
189 WINDING OAKS LANE             SE DECISION MADE: 14-SEP-11
OVIEDO FL 32765                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE INSYNC CERAMIC SYSTEM
JENSEN INDUSTRIES, INC.           510(k) NO: K111743(ABBREVIATED)
ATTN: GARY  PHELPS                PHONE NO : 203 239 2090   
50 STILLMAN RD.                   SE DECISION MADE: 14-SEP-11
NORTH HAVEN CT 06473              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2
ELITECHGROUP                      510(k) NO: K111996(ABBREVIATED)
ATTN: DEBRA K HUTSON              PHONE NO : 425 482 5174   
21720 23RD DR SE SUITE 150        SE DECISION MADE: 14-SEP-11
BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL
BIODENTA SWISS AG                 510(k) NO: K111003(TRADITIONAL)
ATTN: DAVID  EILER                PHONE NO : 417 174 71111
TRAMSTRASSE 16                    SE DECISION MADE: 15-SEP-11
BERNECK, ST. GALLEN    SZ 9442    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC
VORTRAN MEDICAL TECHNOLOGY 1, INC.510(k) NO: K103639(TRADITIONAL)
ATTN: JAMES  LEE                  PHONE NO : 916 648 8460   
21 GOLDEN LAND COURT              SE DECISION MADE: 15-SEP-11
SACRAMENTO CA 95834               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Q-CLEAR
LIGHT AGE, INC.                   510(k) NO: K110370(TRADITIONAL)
ATTN: ELIZABETH  REDDINGTON       PHONE NO : 732 563 0600   
500 APGAR DRIVE                   SE DECISION MADE: 15-SEP-11
SOMERSET NJ 08873 1150            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KOLPLUX SYSTEM
KOLPLAST CI LTDA                  510(k) NO: K110766(TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 410 451 0639   
1468 HARWELL AVENUE               SE DECISION MADE: 15-SEP-11
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FEEL-DRCS
IMFOU CO., LTD                    510(k) NO: K110033(TRADITIONAL)
ATTN: HO DONG  YANG               PHONE NO : 082 256 63360
#821 SAMIL PLAZA, 837-26 YEUKSAM-DSE DECISION MADE: 15-SEP-11
GANGNAM-GU, SEOUL    KS 135-768   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EQUAL DOSE
NUCLETRON CORPORATION             510(k) NO: K103515(TRADITIONAL)
ATTN: MANAL  YOUSOF               PHONE NO : 443 545 2196   
7021 COLUMBIA GATEWAY DR. SUITE 20SE DECISION MADE: 15-SEP-11
COLUMBIA MD 21046 2133            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS
MIS - IMPLANT TECHNOLOGIES LTD.   510(k) NO: K103089(TRADITIONAL)
ATTN: IMAN  KHORSHID              PHONE NO : 972 4 9016800
BAR LEV INDUSTRIAL PARK P.O. BOX 7SE DECISION MADE: 15-SEP-11
BAR LEV INDUSTRIAL PARK    IS 2015510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K111510(TRADITIONAL)
ATTN: KEVIN  FORD                 PHONE NO : 901 396 3133   
1800 PYRAMID PL.                  SE DECISION MADE: 15-SEP-11
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASTRA
CANDELIS, INC.                    510(k) NO: K111694(TRADITIONAL)
ATTN: VINCENT  CIPOLLA            PHONE NO : 949 798 8122   
18821 BARDEEN AVE.                SE DECISION MADE: 15-SEP-11
IRVINE CA 92612                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 4CH FLEX SPEEDER
TOSHIBA MEDICAL SYSTEMS COPORATION510(k) NO: K112366(SPECIAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 MICHELLE DR                  SE DECISION MADE: 15-SEP-11
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
CARDIAC ASSIST, MAQUET CARDIOVASCU510(k) NO: K112372(SPECIAL)
ATTN: HELDER A SOUSA              PHONE NO : 201 995 8710   
1300 MACARTHUR BLVD.              SE DECISION MADE: 15-SEP-11
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC
COOPERVISION, INC.                510(k) NO: K111966(SPECIAL)
ATTN: LISA  HAHN                  PHONE NO : 585 385 6810   
6150 STONERIDGE MALL ROAD SUITE 37SE DECISION MADE: 15-SEP-11
PLEASANTON CA 94588               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT
NESS-NEUROMUSCULAR ELECTRICAL STIM510(k) NO: K111767(TRADITIONAL)
ATTN: MONICA  STACHURA,JD         PHONE NO : 661 362 4844
19 HA'HAROSHET ST.                SE DECISION MADE: 15-SEP-11
RA'ANANA    IS 43654              510(k) STATEMENT

DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK           510(k) NO: K111457(TRADITIONAL)
ATTN: LEE  GRANT                  PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 15-SEP-11
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM
SPINAL USA                        510(k) NO: K112025(TRADITIONAL)
ATTN: FRANKIE  CUMMINS            PHONE NO : 601 420 4244   
2050 EXECUTIVE DR.                SE DECISION MADE: 15-SEP-11
PEARL MS 39208                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOLECULAR BREAST IMAGING SOFTWARE
GAMMA MEDICA-IDEAS INCORPORATED   510(k) NO: K111731(TRADITIONAL)
ATTN: ALBERT  BONISKE             PHONE NO : 408 400 0856   
755 N. MATHILDA AVENUE SUITE 100  SE DECISION MADE: 15-SEP-11
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATHASSIST LIGHT FIBER
ENTELLUS MEDICAL, INC.            510(k) NO: K111763(TRADITIONAL)
ATTN: KAREN E PETERSON            PHONE NO : 763 463 7056   
6705 WEDGWOOD COURT NORTH         SE DECISION MADE: 15-SEP-11
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITEK 2 STRPTOCOCCUS AMPICILLIN
BIOMERIEUX, INC.                  510(k) NO: K112075(TRADITIONAL)
ATTN: JOLYN  TENLLADO             PHONE NO : 314 731 8386   
595 ANGLUM RD.                    SE DECISION MADE: 15-SEP-11
HAZELWOOD MO 63042                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS
APEX BIOTECHNOLOGY CORP.          510(k) NO: K102816(TRADITIONAL)
ATTN: HSUE-MEI  LEE               PHONE NO : 886 356 41952
NO. 7, LI-HSIN ROAD V, HSINCHU SCISE DECISION MADE: 15-SEP-11
HSINCHU    TW 30078               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: R4 ACERT ULTRASOUND REPORTING SYSTEM
R4 LLC                            510(k) NO: K101898(TRADITIONAL)
ATTN: CRISTIAN  NEGRILA           PHONE NO : 440 546 4272   
17999 FOLTZ PARKWAY               SE DECISION MADE: 15-SEP-11
STRONGSVILLE OH 44149             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES
MAQUET CARDIOPULMONARY AG         510(k) NO: K112360(SPECIAL)
ATTN: KATRIN  SCHWENKGLENKS       PHONE NO : 497 478 921373
HECHINGER STRASSE 38              SE DECISION MADE: 15-SEP-11
HIRRLINGEN    GM 72145            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRAGET DETACHABLE COIL
STRYKER NEUROVASCULAR             510(k) NO: K112385(SPECIAL)
ATTN: JAMES  LEATHLEY             PHONE NO : 510 440 7836   
47900 BAYSIDE PARKWAY             SE DECISION MADE: 15-SEP-11
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE
OTTO BOCK HEALTHCARE, LP          510(k) NO: K111278(TRADITIONAL)
ATTN: WILLIAM  KABITZ             PHONE NO : 763 553 9464   
TWO CARLSON PARKWAY NORTH SUITE 10SE DECISION MADE: 16-SEP-11
MINNEAPOLIS MN 55447 4467         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION
CELLAVISION AB                    510(k) NO: K102778(TRADITIONAL)
ATTN: CONSTANCE G BUNDY           PHONE NO : 763 574 1976   
435 RICE CREEK TERRACE NE         SE DECISION MADE: 16-SEP-11
FRIDLEY MN 55432                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGICAL MASKS
SHANGHAI NEO-MEDICAL IMPORT & EXPO510(k) NO: K111559(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 64264468
P.O. BOX 237-023                  SE DECISION MADE: 16-SEP-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS
EV3 INC                           510(k) NO: K111490(SPECIAL)
ATTN: DANIEL  CHER, MD            PHONE NO : 650 566 0057   
173 JEFFERSON DR                  SE DECISION MADE: 16-SEP-11
MENLO PARK CA 94025               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEAUTISEALANT
SHOFU DENTAL CORPORATION          510(k) NO: K111782(TRADITIONAL)
ATTN: DAVID P MORAIS              PHONE NO : 760 736 3277   
1225 STONE DRIVE                  SE DECISION MADE: 16-SEP-11
SAN MARCOS CA 92078               510(k) STATEMENT

DEVICE: ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K112596(TRADITIONAL)
ATTN: SHELLY  PEARCE              PHONE NO : 650 694 5988   
1230 SHOREBIRD WAY                SE DECISION MADE: 16-SEP-11
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PERMASHADE VENEER CEMENT
ULTRADENT PRODUCTS, INC.          510(k) NO: K111836(TRADITIONAL)
ATTN: COREY  JASEPH               PHONE NO : 801 552 5512   
505 WEST 10200 SOUTH              SE DECISION MADE: 16-SEP-11
SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVIAFIT
FLOWMEDIC LTD.                    510(k) NO: K111720(TRADITIONAL)
ATTN: AHAVA  STEIN                PHONE NO : 972 976 70002
20 HATAAS STR. SUITE 102          SE DECISION MADE: 16-SEP-11
KFAR SABA    IS 44425             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
EPS BIO TECHNOLOGY CORP.          510(k) NO: K111728(SPECIAL)
ATTN: YC  LEI                     PHONE NO : 886 366 86868
NO.8 R&D RD III HSINCHU SCIENCE PASE DECISION MADE: 16-SEP-11
HSINCHU CITY, HSINCHU    TW 30077 510(k) STATEMENT

DEVICE: NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
CARTICEPT MEDICAL INC             510(k) NO: K112067(TRADITIONAL)
ATTN: TANYA  EBERLE               PHONE NO : 770 754 3814   
6120 WINDWARD PRKWY SUITE 220     SE DECISION MADE: 16-SEP-11
ALPHARETTA GA 30005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JOURNEY II BCS KNEE SYSTEM
SMITH & NEPHEW, INC.              510(k) NO: K111711(ABBREVIATED)
ATTN: SHEREEN  MYERS              PHONE NO : 901 399 6325   
7135 GOODLET FARMS PARKWAY        SE DECISION MADE: 16-SEP-11
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PICASSO/ PICASSO LITE/ PICASSO PERIO
AMD LASERS, LLC                   510(k) NO: K102359(ABBREVIATED)
ATTN: AMY  SZENTES                PHONE NO : 317 202 9530   
7405 WESTFIELD BLVD.              SE DECISION MADE: 16-SEP-11
INDIANAPOLIS IN 46240             510(k) STATEMENT

DEVICE: DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM
DELBIO INCORPORATION              510(k) NO: K100806(TRADITIONAL)
ATTN: NICKY  PAN                  PHONE NO : 886 335 96268#8672
3F, NO. 252, SHANGYING ROAD GUISHASE DECISION MADE: 16-SEP-11
TAOYUAN COUNTY    TW 33341        510(k) STATEMENT

DEVICE: TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001
ENCORE MEDICAL, L.P.              510(k) NO: K111629(TRADITIONAL)
ATTN: TEFFANY  HUTTO              PHONE NO : 512 834 6255   
9800 METRIC BLVD.                 SE DECISION MADE: 16-SEP-11
AUSTIN TX 78758                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S8 DIAGNOSTIC ULTRASOUND SYSTEM
SONOSCAPE COMPANY LIMITED         510(k) NO: K112451(SPECIAL)
ATTN: DIANA  HONG                 PHONE NO : 821 228 15850
P.O. BOX 237-023                  SE DECISION MADE: 16-SEP-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EDLEN IMAGING - GEMINI DUSB
EDLEN IMAGING LLC                 510(k) NO: K103290(ABBREVIATED)
ATTN: FELIX  HOVSEPIAN            PHONE NO : 602 524 9611   
3707 N 7TH STREET SUITE 125       SE DECISION MADE: 19-SEP-11
PHOENIX AZ 85014                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NXSTAGE PUREFLOW SL
NXSTAGE MEDICAL, INC.             510(k) NO: K111174(SPECIAL)
ATTN: MARY LOU  STROUMBOS         PHONE NO : 978 687 4872   
439 SOUTH UNION ST., 5TH FLOOR    SE DECISION MADE: 19-SEP-11
LAWRENCE MA 01843                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE
BIONOSTICS, INC.                  510(k) NO: K112356(TRADITIONAL)
ATTN: RANDY  BYRD                 PHONE NO : 978 772 7070   
7 JACKSON RD.                     SE DECISION MADE: 19-SEP-11
DEVENS MA 01434                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K112236(TRADITIONAL)
ATTN: JOE  SHIA                   PHONE NO : 240 505 7880   
504 EAST DIAMOND AVE. SUITE F     SE DECISION MADE: 19-SEP-11
GAITHERSBURG MD 20878             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOBILETT MIRA
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K111912(SPECIAL)
ATTN: PATRICIA D JONES            PHONE NO : 610 484 3536   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 19-SEP-11
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROCEDURAL STRECHER WITH INTELLIDRIVE P8000
HILL-ROM CO.                      510(k) NO: K112502(TRADITIONAL)
ATTN: CHAD  HODSON                PHONE NO : 812 934 1278   
1069 STATE RT. 46 EAST            SE DECISION MADE: 19-SEP-11
BATESVILLE IN 47006 9167          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY
IRIS MOLECULAR DIAGNOSTICS        510(k) NO: K101185(TRADITIONAL)
ATTN: ROBERT  KLEM                PHONE NO : 760 438 9923   
2075 CORTE DEL NOGAL SUITE J      SE DECISION MADE: 20-SEP-11
CARLSBAD CA 92011                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMSCO CHIMERON SMALL STEAM STERILIZER
STERIS CORPORATION                510(k) NO: K111223(ABBREVIATED)
ATTN: ROBERT F SULLIVAN           PHONE NO : 440 392 7695   
5960 HEISLEY ROAD                 SE DECISION MADE: 20-SEP-11
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM
ZYNEX MEDICAL, INC.               510(k) NO: K111279(ABBREVIATED)
ATTN: JIM  ARNOLD                 PHONE NO : 303 703 4906   
9990 PARK MEADOWS DR              SE DECISION MADE: 20-SEP-11
LONE TREE CO 80124                510(k) STATEMENT

DEVICE: TANDEMHEART PUMP
CARDIACASSIST INC.                510(k) NO: K110493(TRADITIONAL)
ATTN: ROBERT  BOLLINGER           PHONE NO : 412 963 7770   
240 ALPHA DRIVE                   SE DECISION MADE: 20-SEP-11
PITTSBURGH PA 15238               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPACER-K, SPACER-G, SPACER-S
TECRES SPA                        510(k) NO: K101356(TRADITIONAL)
ATTN: CHRISTINE  BRAUER           PHONE NO : 301 545 1990   
7 TRAIL HOUSE COURT               SE DECISION MADE: 20-SEP-11
ROCKVILLE MD 20850                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX
MICROVENTION, INC.                510(k) NO: K111451(TRADITIONAL)
ATTN: LARAINE  PANGELINA          PHONE NO : 714 247 8000   
1311 VALENCIA AVE                 SE DECISION MADE: 20-SEP-11
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERALAS 147NM DIODE LASER SYSTEM
BIOLITEC, INC.                    510(k) NO: K112253(TRADITIONAL)
ATTN: HARRY  HAYES                PHONE NO : 413 250 0779   
1349 MAIN ROAD                    SE DECISION MADE: 20-SEP-11
GRANVILLE MA 01034                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE
MOLNLYCKE HEALTH CARE US, LLC     510(k) NO: K112257(SPECIAL)
ATTN: ANGELA L BUNN               PHONE NO : 678 250 7930   
5550 PEACHTREE PARKWAY SUITE 500  SE DECISION MADE: 20-SEP-11
NORCROSS GA 30092                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SORIN CENTRIFUGAL PUMP 5 (CP5)
SORIN GROUP DEUTSCHLAND GMBH      510(k) NO: K112225(SPECIAL)
ATTN: ROSINA  ROBINSON            PHONE NO : 508 643 0434   
49 PLAIN STREET                   SE DECISION MADE: 20-SEP-11
NORTH ATTLEBORO MA 02760          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NT 2000 LESIONING GENERATOR
NEUROTHERM, INC.                  510(k) NO: K111576(TRADITIONAL)
ATTN: F. DAVID  ROTHKOPF          PHONE NO : 617 899 3449   
200 HOMER AVE                     SE DECISION MADE: 20-SEP-11
ASHLAND MA 01721                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FULL AUTO TONOMETER MODEL TX-20
CANON, INC.-MEDICAL EQUIPMENT GROU510(k) NO: K111710(SPECIAL)
ATTN: KOJI  KUBO                  PHONE NO : 81 42 5481253
C/O COSMOS CORPORATION 3F 2-17-6 ASE DECISION MADE: 20-SEP-11
TACHIKAWA-SHI, TOKYO    JA 190-001510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM
ROCHE DIAGNOSTICS                 510(k) NO: K101299(TRADITIONAL)
ATTN: ANDRENE  HERON              PHONE NO : 317 521 2150   
9115 HAGUE ROAD                   SE DECISION MADE: 21-SEP-11
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K110061(ABBREVIATED)
ATTN: ERNEST  JOSEPH              PHONE NO : 914 524 2431   
511 BENEDICT AVENUE               SE DECISION MADE: 21-SEP-11
TARRYTOWN NY 10591 5097           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM
US DIAGNOSTICS, INC.              510(k) NO: K110435(SPECIAL)
ATTN: JONATHAN  JOHNSON           PHONE NO : 646 454 5401   
304 PARK AVENUE SOUTH SUITE 218   SE DECISION MADE: 21-SEP-11
NEW YORK NY 10010 4301            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRIPLE LUMEN PFM PICC
PFM MEDICAL, INC                  510(k) NO: K110914(TRADITIONAL)
ATTN: SALVADORE  PALOMARES        PHONE NO : 760 758 8749   
1815 ASTON AVE SUITE 106          SE DECISION MADE: 21-SEP-11
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE
INMED GLOVES FACTORY              510(k) NO: K111857(TRADITIONAL)
ATTN: XIAOBING  LI                PHONE NO : 865 362 197070
10-2 XING'AN RD. EAST, LINQU,     SE DECISION MADE: 21-SEP-11
WEIFANG, SHANDONG    CH 262600    510(k) STATEMENT

DEVICE: VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET
NUCLETRON                         510(k) NO: K111973(SPECIAL)
ATTN: MICHAEL  PAUL               PHONE NO : 443 545 2182   
7021 COLUMBIA GATEWAY DR SUITE 200SE DECISION MADE: 21-SEP-11
Columbia MD 21046                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING
CARDINAL HEALTH-MEDICAL PRODUCTS A510(k) NO: K111868(TRADITIONAL)
ATTN: TATYANA  BOGDAN             PHONE NO : 847 887 2325   
1430 WAUKEGAN RD.                 SE DECISION MADE: 21-SEP-11
MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIRTUE
DIAGNOSOFT, INC.                  510(k) NO: K111833(TRADITIONAL)
ATTN: JEFFREY  ROBERTS            PHONE NO : 508 643 0434   
49 PLAIN STREET                   SE DECISION MADE: 21-SEP-11
NORTH ATTLEBORO MA 02760          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CMS-1000FM CENTRAL MONITORING SYSTEM
ADVANCED INSTRUMENTATIONS, INC.   510(k) NO: K112159(TRADITIONAL)
ATTN: JORGE  MILLAN               PHONE NO : 305 925 1260   
601 WEST 20 ST                    SE DECISION MADE: 21-SEP-11
HIALEAH FL 33010                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FM-1000 PLUS FETAL MONITOR
ADVANCED INSTRUMENTATIONS, INC.   510(k) NO: K112187(TRADITIONAL)
ATTN: JORGE  MILLAN               PHONE NO : 305 925 1260   
601 W 20 ST                       SE DECISION MADE: 21-SEP-11
HIALEAH FL 33010                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD
ORTHO DEVELOPMENT                 510(k) NO: K111936(SPECIAL)
ATTN: TOM  HAUETER                PHONE NO : 801 553 9991   
12187 S. BUSINESS PARK DR.        SE DECISION MADE: 21-SEP-11
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Z BOND, PRELUDE ONE
DANVILLE MATERIALS, INC.          510(k) NO: K111876(TRADITIONAL)
ATTN: LINDSAY  TILTON             PHONE NO : 925 973 0710   
3420 FOSTORIA WAY, SUITE A-200    SE DECISION MADE: 21-SEP-11
SAN RAMON CA 94583                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ODALYS PEDICLE SCREW SYSTEM
KALITEC DIRECT, LLC               510(k) NO: K111370(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 21-SEP-11
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORONIS FUSION 4MP DL
BARCO NV                          510(k) NO: K111989(SPECIAL)
ATTN: LIEVEN  DE WANDEL           PHONE NO : 325 623 3459
35 PRESIDENT KENNEDYPARK          SE DECISION MADE: 22-SEP-11
KORTRIJK    BE 8500               510(k) STATEMENT

DEVICE: OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT
OSTEOSYMBIONICS, LLC              510(k) NO: K111069(TRADITIONAL)
ATTN: ELAINE  DUNCAN              PHONE NO : 715 549 6035   
P.O. BOX 560                      SE DECISION MADE: 22-SEP-11
STILLWATER MN 55082               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT
RHYTHMLINK INTERNATIONAL, LLC     510(k) NO: K112435(SPECIAL)
ATTN: JAMES  MEWBORNE             PHONE NO : 803 252 1222   
1140 FIRST STREET SOUTH           SE DECISION MADE: 22-SEP-11
COLUMBIA SC 29209                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RADIFORCE LARGE MONITOR SYSTEM
EIZO GMBH                         510(k) NO: K112645(TRADITIONAL)
ATTN: BERND  HOMBERG              PHONE NO : 497 212 0321220
SIEMENSALLEE 84 D-76187           SE DECISION MADE: 22-SEP-11
KARLSRUBE    GM                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CORELEADER SCAR-DIMMER
CORELEADER BIOTECH CO., LTD.      510(k) NO: K111733(TRADITIONAL)
ATTN: IAN  LI                     PHONE NO : 886 226 9688880
19F NO. 100, SEC 1 SINTAI 5TH RD, SE DECISION MADE: 22-SEP-11
NEW TAIPEI, TAIWAN    TW 22102    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSITITRE OPTIREAD
TREK DIAGNOSTIC SYSTEMS, LTD.     510(k) NO: K110583(TRADITIONAL)
ATTN: CYNTHIA C KNAPP             PHONE NO : 216 351 8735   
982 KEYNOTE CIRCLE SUITE 6        SE DECISION MADE: 22-SEP-11
CLEVELAND OH 44131                510(k) STATEMENT

DEVICE: RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE
VASCULAR PATHWAYS, INC.           510(k) NO: K112347(SPECIAL)
ATTN: MICHAEL A DANIEL            PHONE NO : 925 254 5228   
8 SNOWBERRY COURT                 SE DECISION MADE: 22-SEP-11
ORINDA CA 94563                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 27 G X 1/2" K-PACK SURSHIELD NEEDLE
TERUMO EUROPE N.V.                510(k) NO: K111797(SPECIAL)
ATTN: M.J.  AERTS                 PHONE NO : 320 163 81211
INTERLEUVENLAAN 40                SE DECISION MADE: 22-SEP-11
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
ADVANCED INSTRUMENTATIONS, INC.   510(k) NO: K112022(TRADITIONAL)
ATTN: JORGE  MILLAN               PHONE NO : 305 925 1260   
601 WEST 20 ST                    SE DECISION MADE: 22-SEP-11
HIALEAH FL 33010                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL ELECTROCARDIOGRAPH
SHENZHEN BIOCARE ELECTRONICS CO., 510(k) NO: K112431(SPECIAL)
ATTN: DIANA  HONG                 PHONE NO : 86 212 2815850
P.O. BOX 237-023                  SE DECISION MADE: 22-SEP-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES
HOWMEDICA OSTEONICS CORP DBA STRYK510(k) NO: K112455(SPECIAL)
ATTN: STEPHANIE  FITTS            PHONE NO : 201 831 5405   
325 CORPORATE DRIVE               SE DECISION MADE: 22-SEP-11
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PD-100 SERIES ULTRASONIC POCKET DOPPLER
ADVANCED INSTRUMENTATIONS, INC.   510(k) NO: K111934(TRADITIONAL)
ATTN: JORGE  MILLAN               PHONE NO : 305 925 1260   
601 WEST 20 ST                    SE DECISION MADE: 22-SEP-11
HIALEAH FL 33010                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PULSIOFLEX
PULSION MEDICAL SYSTEMS, INC.     510(k) NO: K112448(SPECIAL)
ATTN: JAMIE  SULLEY               PHONE NO : 919 426 4023   
1511 ESSEX RD                     SE DECISION MADE: 22-SEP-11
WESTBROOK CT 06498                510(k) STATEMENT

DEVICE: MAMMODIAGNOST DR
PHILIPS MEDICAL SYSTEMS           510(k) NO: K110572(TRADITIONAL)
ATTN: LINDA  JALBERT              PHONE NO : 978 659 7434   
3000 MINUTEMAN RD.                SE DECISION MADE: 23-SEP-11
ANDOVER MA 01810 1099             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RHYTHMVIEW (TM)
TOPERA, INC.                      510(k) NO: K110878(TRADITIONAL)
ATTN: RUCHIR  SEHRA               PHONE NO : 858 367 3395   
11445 E. VIA LINDA SUITE 2, P.O. BSE DECISION MADE: 23-SEP-11
SCOTTSDALE AZ 85259               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK
KIMBERLY-CLARK                    510(k) NO: K103150(TRADITIONAL)
ATTN: ANN  WATERHOUSE             PHONE NO : 678 352 6719   
1400 HOLCOMB BRIDGE ROAD SUITE 115SE DECISION MADE: 23-SEP-11
ROSWELL GA 30076                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY
ENDOSCOPIC TECHNOLOGIES, INC. D/B/510(k) NO: K110913(SPECIAL)
ATTN: TAMER  IBRAHIM              PHONE NO : 925 543 2110   
2603 CAMINO RAMON SUITE 100       SE DECISION MADE: 23-SEP-11
SAN RAMON CA 94583                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: "UNITED" 36MM CERAMIC FEMORAL HEAD, DELTA
UNITED ORTHOPEDIC CORPORATION     510(k) NO: K112463(SPECIAL)
ATTN: FANG-YUAN  HO               PHONE NO : 886 357 73351
NO 57, PARK AVE 2, SCIENCE PARK   SE DECISION MADE: 23-SEP-11
HSINCHU    TW 300                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRASEAL XT HYDRO
ULTRADENT PRODUCTS, INC.          510(k) NO: K112517(SPECIAL)
ATTN: DIANE  ROGERS               PHONE NO : 801 553 4491   
505 WEST 10200 SOUTH              SE DECISION MADE: 23-SEP-11
SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORELEADER COLLA-ALGI FIBER MODEL CAW
CORELEADER BIOTECH CO., LTD.      510(k) NO: K111578(TRADITIONAL)
ATTN: IAN  LI                     PHONE NO : 886 2 26968880
19F NO. 100, SEC 1 SINTAI 5TH RD, SE DECISION MADE: 23-SEP-11
TAIPEI, TAIWAN    TW 22102        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CS 7600
CARESTREAM HEALTH, INC.           510(k) NO: K111649(TRADITIONAL)
ATTN: DANIEL  HOEFER              PHONE NO : 770 226 3287   
1765 THE EXCHANGE                 SE DECISION MADE: 23-SEP-11
ATLANTA GA 30339                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LUMAGEM MOLECULAR BREAST IMAGING SYSTEM
GAMMA MEDICA-IDEAS INCORPORATED   510(k) NO: K111791(TRADITIONAL)
ATTN: ALBERT  BONISKE             PHONE NO : 408 400 0856   
755 N. MATHILDA AVENUE SUITE 100  SE DECISION MADE: 23-SEP-11
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACQPOINT THERMAJADE MASSAGE TABLE
ACQPOINT, INC.                    510(k) NO: K102938(TRADITIONAL)
ATTN: MORRIS  SHEPPARD            PHONE NO : 760 636 6811   
79-825 HIGHWAY 111, SUITE 101     SE DECISION MADE: 23-SEP-11
LA QUINTA CA 92253                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K112071(TRADITIONAL)
ATTN: JOE  SHIA                   PHONE NO : 240 505 7880   
504 EAST DIAMOND AVE. SUITE F     SE DECISION MADE: 23-SEP-11
GAITHERSBRUG MD 20878             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLANMED NUANCE EXCEL
PLANMECA USA, INC.                510(k) NO: K111361(TRADITIONAL)
ATTN: BOB  PIENKOWSKI             PHONE NO : 630 529 2300   
100 N. GARY AVE. SUITE A          SE DECISION MADE: 23-SEP-11
ROSELLE IL 60172                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS
MASIMO CORPORATION                510(k) NO: K111888(SPECIAL)
ATTN: ANIL  BHALANI               PHONE NO : 949 297 7000   
40 AND 50 PARKER                  SE DECISION MADE: 23-SEP-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE
CEDARS-SINAI MEDICAL CENTER       510(k) NO: K112474(SPECIAL)
ATTN: GEOFF  POLLARD              PHONE NO : 310 423 4663   
8700 BEVERLY BLVD                 SE DECISION MADE: 23-SEP-11
LOS ANGELES CA 90048              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENUE 40
GE HEALTHCARE                     510(k) NO: K112122(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 INNOVATION DRIVE             SE DECISION MADE: 23-SEP-11
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PASS LP SPINAL SYSTEM
MEDICREA INTERNATIONAL            510(k) NO: K110497(SPECIAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 26-SEP-11
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASTRA TECH IMPLANT SYSTEM
ASTRA TECH AB                     510(k) NO: K111287(TRADITIONAL)
ATTN: LINDA K SCHULZ              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL, SUITE 200   SE DECISION MADE: 26-SEP-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE
KEPLER MEDTEC                     510(k) NO: K110462(TRADITIONAL)
ATTN: SHARYN  ORTON, PHD          PHONE NO : 401 330 8264   
200 HOMER AVE                     SE DECISION MADE: 26-SEP-11
ASHLAND MA 01721                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TEPHAFLEX MESH
TEPHA, INC.                       510(k) NO: K111946(TRADITIONAL)
ATTN: MARY P LEGRAW               PHONE NO : 781 357 1709   
99 HAYDEN AVENUE, SUITE 360       SE DECISION MADE: 26-SEP-11
LEXINGTON MA 02421                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REPROCESSED ELECTROPHYSIOLOGY CATHETERS
STRYKER SUSTAINABILITY SOLUTIONS  510(k) NO: K112232(TRADITIONAL)
ATTN: AMANDA  BABCOCK             PHONE NO : 480 763 5376   
5307 Great Oak Dr                 SE DECISION MADE: 26-SEP-11
LAKELAND FL 33815                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INQU PASTE MIX
ISTO TECHNOLOGIES, INC.           510(k) NO: K111838(TRADITIONAL)
ATTN: PATSY J TRISLER             PHONE NO : 301 652 5344   
5600 WISCONSIN AVE. #509          SE DECISION MADE: 26-SEP-11
CHEVY CHASE MD 20815              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SELECTRA ACCESSORY KIT
BIOTRONIK, INC.                   510(k) NO: K111839(TRADITIONAL)
ATTN: JON  BRUMBAUGH              PHONE NO : 888 345 0374   
6024 JEAN ROAD                    SE DECISION MADE: 26-SEP-11
LAKE OSWEGO OR 97035              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS
BIOMATERIALS KOREA INC.           510(k) NO: K111809(SPECIAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
5401 S. COTTONWOOD CT.            SE DECISION MADE: 26-SEP-11
GREENWOOD VILLAGE CO 80121        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HAIRMAX LASERCOMB
LEXINGTON INTERNATIONAL, LLC      510(k) NO: K112524(SPECIAL)
ATTN: DAVID  MICHAELS             PHONE NO : 561 314 2430   
777 YAMATO RD., SUITE 105         SE DECISION MADE: 26-SEP-11
BOCA RATON FL 33431               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE ESPINER SAC OR E SAC
ESPINER MEDICAL LIMITED           510(k) NO: K111845(TRADITIONAL)
ATTN: EDWIN  LINDSAY              PHONE NO : 004 479 17134922
116 ALMOND ROAD, CUMBERNAULD      SE DECISION MADE: 26-SEP-11
GLASGOW    UK G673LW              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE
GE HEALTHCARE INTEGRATED IT SOLUTI510(k) NO: K111614(TRADITIONAL)
ATTN: JEME  WALLACE               PHONE NO : 847 277 4468   
540 W. NW HIGHWAY                 SE DECISION MADE: 26-SEP-11
BARRINGTON IL 60010               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR
TOTOKU ELECTRIC CO., LTD          510(k) NO: K111496(TRADITIONAL)
ATTN: TSUKASA  TASHIRO            PHONE NO : 812 582 46611
300 OYA                           SE DECISION MADE: 26-SEP-11
UEDA, NAGANO    JA 386-0192       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE
SPINEOLOGY INC.                   510(k) NO: K111880(TRADITIONAL)
ATTN: BRYAN  BECKER               PHONE NO : 651 256 8500   
7800 THIRD STREET N. SUITE 600    SE DECISION MADE: 26-SEP-11
Saint Paul MN 55128               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGICASE ORTHOGNATHIC SOFTWARE WIZARD
MATERIALISE N.V.                  510(k) NO: K111641(TRADITIONAL)
ATTN: OLIVER  CLEMENS             PHONE NO : 32 16 744537
TECHNOLOGIELAAN 15                SE DECISION MADE: 26-SEP-11
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SELECTRA SLITTER TOOL
BIOTRONIK, INC.                   510(k) NO: K112482(SPECIAL)
ATTN: JON  BRUMBAUGH              PHONE NO : 888 345 0374   
6024 JEAN ROAD                    SE DECISION MADE: 26-SEP-11
LAKE OSWEGO OR 97035              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXETER HIP STEM
HOWMEDICA OSTEONICS CORP          510(k) NO: K110290(TRADITIONAL)
ATTN: VALERIE  GIAMBANCO          PHONE NO : 201 831 6275   
325 CORPORATE DR.                 SE DECISION MADE: 27-SEP-11
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: META-LOCK SUTURE ANCHOR SYSTEM
TARSUS MEDICAL INC.               510(k) NO: K110800(TRADITIONAL)
ATTN: NICHOLAS  MOURLAS           PHONE NO : 650 237 0070   
465 FAIRCHILD DRIVE SUITE 230     SE DECISION MADE: 27-SEP-11
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NMR LIPOPROFILE (R) TEST AND NMR PROFILER
LIPOSCIENCE, INC                  510(k) NO: K111516(TRADITIONAL)
ATTN: SUZETTE M WARNER            PHONE NO : 919 256 1326   
2500 Sumner Blvd                  SE DECISION MADE: 27-SEP-11
Raleigh NC 27616                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOGIQ P3
GE HEALTHCARE                     510(k) NO: K112371(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 W. INNOVATION DRIVE          SE DECISION MADE: 27-SEP-11
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RADIAL ARTERY COMPRESSION TOURNIQUET
LEPU MEDICAL TECHNOLOGY (BEIJING) 510(k) NO: K111837(TRADITIONAL)
ATTN: SHAN  ZHAO                  PHONE NO : 861 080 120641
NO. 37 CHAOQIAN ROAD              SE DECISION MADE: 27-SEP-11
BEIJING, CHANGPING DISTRICT    CH 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON(R) SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K112555(SPECIAL)
ATTN: CHRIS  MCKEE                PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 27-SEP-11
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K110673(TRADITIONAL)
ATTN: DOUG  THISTLETHWAITE        PHONE NO : 330 425 1313   
1959 SUMMIT COMMERCE PARK         SE DECISION MADE: 27-SEP-11
TWINSBURG OH 44087                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN
BIOMERIEUX, INC.                  510(k) NO: K112129(TRADITIONAL)
ATTN: JOLYN  TENLLADO             PHONE NO : 314 731 8386   
595 ANGLUM RD.                    SE DECISION MADE: 27-SEP-11
HAZELWOOD MO 63042                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION
I-SENS, INC.                      510(k) NO: K103396(SPECIAL)
ATTN: STANLEY R GOODMAN           PHONE NO : 516 227 2100   
100 GARDEN CITY PLAZA, SITE 412B  SE DECISION MADE: 27-SEP-11
GARDEN CITY NY 11530              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISOAMP HSV ASSAY
BIOHELIX CORPORATION              510(k) NO: K111951(TRADITIONAL)
ATTN: FRAN  WHITE                 PHONE NO : 978 972 3808   
32 TOZER RD                       SE DECISION MADE: 27-SEP-11
BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONIX ULTRASOUND SCANNER
ULTRASONIX MEDICAL CORPORATION    510(k) NO: K112726(TRADITIONAL)
ATTN: CHAS  YU                    PHONE NO : 604 279 8550
130-4311 VIKING WAY               SE DECISION MADE: 27-SEP-11
RICHMOND, BRITISH COLUMBIA    CA V510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM
ABBOTT MEDICAL OPTICS INC         510(k) NO: K111697(ABBREVIATED)
ATTN: OPHELIA  BIGGS              PHONE NO : 714 247 8614   
1700 E. ST. ANDREW PLACE          SE DECISION MADE: 27-SEP-11
SANTA ANA CA 92705                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LITE-MED LM-9200 ELMA
LITE-MED INC                      510(k) NO: K103217(ABBREVIATED)
ATTN: WALT  HSU                   PHONE NO : 886 229 154183
9TH FLOOR, 49 DONGXING ROAD XINYI SE DECISION MADE: 28-SEP-11
TAIPEI CITY    TW 110             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINEFRONTIER LUMBAR IBF SYSTEM
SPINEFRONTIER, INC.               510(k) NO: K111553(ABBREVIATED)
ATTN: HANNAH  CROWE               PHONE NO : 978 232 3990   
500 CUMMINGS CENTER, STE. 3500    SE DECISION MADE: 28-SEP-11
BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AURIGA XL
STARMEDTEC GMBH                   510(k) NO: K111475(TRADITIONAL)
ATTN: GREGOR  WEIDEMANN           PHONE NO : 498 151 268610
KREUZSTRASSE 22                   SE DECISION MADE: 28-SEP-11
STARNBERG    GM 82319             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PALINDROME H, SI, HSI CHRONIC CATHETER
COVIDIEN                          510(k) NO: K112477(SPECIAL)
ATTN: WING  NG                    PHONE NO : 508 261 6596   
15 HAMPSHIRE STREET               SE DECISION MADE: 28-SEP-11
MANSFIELD MA 02048                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIONEER CROSSFUSE II IBF/VBR SYSTEM
PIONEER SURGICAL TECHNOLOGY, INC. 510(k) NO: K112496(SPECIAL)
ATTN: EMILY M DOWNS               PHONE NO : 906 225 5602   
375 RIVER PARK CIRCLE             SE DECISION MADE: 28-SEP-11
MARQUETTE MI 49855                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
HOWMEDICA OSTEONICS CORP          510(k) NO: K112556(SPECIAL)
ATTN: VALERIE  GIAMBANCO          PHONE NO : 201 831 3275   
325 CORPORATE DR.                 SE DECISION MADE: 28-SEP-11
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: X12 STERILE RELFECTIVE MARKER SPHERE
PINSCO INC. DBA B & L ENGINEERING 510(k) NO: K111443(TRADITIONAL)
ATTN: LEE A BARNES                PHONE NO : 714 505 9492   
1901 CARNEGIE AVENUE SUITE Q      SE DECISION MADE: 29-SEP-11
SANTA ANA CA 92705                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEODYNE DRESSING
NEODYNE BIOSCIENCES, INC.         510(k) NO: K112131(TRADITIONAL)
ATTN: PEGGY  MCLAUGHLIN           PHONE NO : 650 504 8501   
127 INDEPENDENCE DRIVE            SE DECISION MADE: 29-SEP-11
MENLO PARK CA 94025               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SCEPTER C OCCLUSION BALLOON CATHETER
MICROVENTION, INC.                510(k) NO: K110741(TRADITIONAL)
ATTN: NAOMI  GONG                 PHONE NO : 714 247 8055   
1311 VALENCIA AVE                 SE DECISION MADE: 29-SEP-11
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLE
M.V. S.R.L.                       510(k) NO: K110606(TRADITIONAL)
ATTN: ENRICO  BISSON              PHONE NO : 39 049 8630080
VIA MARZIA 9                      SE DECISION MADE: 29-SEP-11
ABANO TERME PADOVA    IT 35031    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR
THAYER MEDICAL CORPORATION        510(k) NO: K111570(TRADITIONAL)
ATTN: ERIKA S STRICKLAND          PHONE NO : 520 790 5393   
4575 SOUTH PALO VERDE Road SUITE 3SE DECISION MADE: 29-SEP-11
TUCSON AZ 85714 1961              510(k) STATEMENT

DEVICE: MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM
MEDICAM INC.                      510(k) NO: K111350(TRADITIONAL)
ATTN: PHILIPPE  AMAR              PHONE NO : 514 737 0404
7900 JEAN-BRILLON                 SE DECISION MADE: 29-SEP-11
MONTREAL, QUEBEC    CA H8N 2L5    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT
INTUITIVE SURGICAL, INC.          510(k) NO: K112584(SPECIAL)
ATTN: KIM T SERVANCE              PHONE NO : 408 523 2100   
950 KIFER RD.                     SE DECISION MADE: 29-SEP-11
SUNNYVALE CA 94086 5206           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION
BD MEDICAL SURGICAL               510(k) NO: K112434(TRADITIONAL)
ATTN: JOHN  ROBERTS               PHONE NO : 201 847 5473   
ONE BECTON DR. MC237              SE DECISION MADE: 29-SEP-11
FRANKLIN LAKES NJ 07417 1880      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EQUIMATRIX
LUITPOLD PHARMACEUTICALS, INC.    510(k) NO: K111816(ABBREVIATED)
ATTN: MARSHA  SIMON               PHONE NO : 610 650 4200   
ONE LUITPOLD DR. P.O. BOX 9001    SE DECISION MADE: 29-SEP-11
SHIRLEY NY 11967                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
PAREXELINTERNATIONAL              510(k) NO: K112525(SPECIAL)
ATTN: BARRY  SALL                 PHONE NO : 781 434 4742   
195 WEST STREET                   SE DECISION MADE: 29-SEP-11
WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMG SYSTEM
MYOTRONICS-NOROMED, INC.          510(k) NO: K111687(SPECIAL)
ATTN: F.  ADIB                    PHONE NO : 206 243 4214   
5870 S. 194TH ST.                 SE DECISION MADE: 29-SEP-11
KENT WA 98032 2126                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID
HERAEUS KULZER, LLC               510(k) NO: K111832(TRADITIONAL)
ATTN: CHERYL  ZIMMERMAN           PHONE NO : 574 299 5444   
300 HERAEUS WAY                   SE DECISION MADE: 29-SEP-11
SOUTH BEND IN 46614               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET
US INFUSION DBA TRUECARE BIOMEDIX 510(k) NO: K111351(ABBREVIATED)
ATTN: AARON  COMPTON              PHONE NO : 866 593 8444   
2003 NW 79TH AVE.                 SE DECISION MADE: 29-SEP-11
MIAMI FL 33122                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
CONFORMIS, INC.                   510(k) NO: K111916(TRADITIONAL)
ATTN: AMITA S SHAH                PHONE NO : 781 345 9164   
11 NORTH AVENUE                   SE DECISION MADE: 29-SEP-11
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE
KUNSHAN JIEHONG NONWOVEN PRODUCT C510(k) NO: K112136(TRADITIONAL)
ATTN: GLEN  FEYE                  PHONE NO : 619 517 1762   
1340 WEST PENNSYLVANIA AVE        SE DECISION MADE: 29-SEP-11
SAN DIEGO CA 92103                510(k) STATEMENT

DEVICE: PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES
CARDINAL HEALTH, INC.             510(k) NO: K111878(TRADITIONAL)
ATTN: TATYANA  BOGDAN             PHONE NO : 847 887 2325   
1430  WAUKEGAN ROAD               SE DECISION MADE: 29-SEP-11
MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYDROCOIL EMBOLIC SYSTEM (HES)
MICROVENTION, INC.                510(k) NO: K112226(SPECIAL)
ATTN: LARAINE  PANGELINA          PHONE NO : 714 247 8150   
1311 VALENCIA AVE                 SE DECISION MADE: 29-SEP-11
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AGILLS PF DELIVERY SYSTEM
ST. JUDE MEDICAL, CARDIAC RHYTHM M510(k) NO: K111943(TRADITIONAL)
ATTN: GEENA  GEORGE               PHONE NO : 818 493 2629   
15900 VALLEY VIEW CT.             SE DECISION MADE: 29-SEP-11
SYLMAR CA 91342                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHARTIS CATHETER MODEL CHR-CA-12.0
PULMONX, INC.                     510(k) NO: K111522(SPECIAL)
ATTN: HANS  SCHULZ                PHONE NO : 650 364 0400   
700 CHESAPEAKE DRIVE              SE DECISION MADE: 29-SEP-11
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUROVISION NERVE LOCATOR MONITOR
NEUROVISION MEDICAL PRODUCTS, INC.510(k) NO: K110140(TRADITIONAL)
ATTN: CHRISTINE  VERGELY          PHONE NO : 805 866 6999   
2225 SPERRY AVE, SUITE 1000       SE DECISION MADE: 30-SEP-11
VENTURA CA 93003                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
RANDOX LABORATORIES LIMITED       510(k) NO: K110846(TRADITIONAL)
ATTN: PAULINE  ARMSTRONG          PHONE NO : 440 28 94422413
55 DIAMOND ROAD CRUMLIN           SE DECISION MADE: 30-SEP-11
CRUMLIN  ANTRIM    UK BT29 4QY    510(k) STATEMENT

DEVICE: DISCOVERY MR750W 3.0T
GE HEALTHCARE JAPAN CORPORATION   510(k) NO: K103327(TRADITIONAL)
ATTN: TORU  SHIMIZU               PHONE NO : 814 258 55344
7-127, ASAHIGAOKA 4-CHROME        SE DECISION MADE: 30-SEP-11
HINO-SHI, TOKYO    JA 191-8503    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FREERIDER MODEL LUGGIE MODEL 168-4IT
FREERIDER LUGGIE SCOOTERS INC     510(k) NO: K110165(TRADITIONAL)
ATTN: JEFFREY L DAVIS             PHONE NO : 951 237 6192   
4500 COUNTRY GLEN COURT           SE DECISION MADE: 30-SEP-11
RIVERSIDE CA 92505                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAPERLOC COMPLETE MICROPLASTY STEM
BIOMET MANUFACTURING CORP.        510(k) NO: K110400(TRADITIONAL)
ATTN: BECKY  EARL                 PHONE NO : 574 267 6639   
PO BOX 587                        SE DECISION MADE: 30-SEP-11
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
RANDOX LABORATORIES, LTD.         510(k) NO: K110904(TRADITIONAL)
ATTN: PAULINE  ARMSTRONG          PHONE NO : 440 289 4422413
55 DIAMOND RD.                    SE DECISION MADE: 30-SEP-11
CRUMLIN, COUNTY ANTRIM    UK BT29 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
PHADIA US INC.                    510(k) NO: K102673(TRADITIONAL)
ATTN: MARTIN M MANN               PHONE NO : 269 492 1957   
4169 COMMERCIAL AVE.              SE DECISION MADE: 30-SEP-11
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGIMAP (TM) SPINE
NEMARIS INC                       510(k) NO: K111019(TRADITIONAL)
ATTN: KEITH A BARRITT             PHONE NO : 202 783 5070   
1425 K STREET N.W. 11TH FLOOR     SE DECISION MADE: 30-SEP-11
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LDR SPINE ROI-A INTERBODY FUSION SYSTEM
LDR SPINE USA                     510(k) NO: K110327(SPECIAL)
ATTN: MARITZA  ELIAS              PHONE NO : 512 344 3371   
4030 WEST BRAKER LANE SUITE 360   SE DECISION MADE: 30-SEP-11
AUSTIN TX 78759                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHILIPS INTELLIVUE TCG10
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K110474(ABBREVIATED)
ATTN: JENS-PETER  SEHER           PHONE NO : 497 031 4632086
HEWLETT-PACKARD STR.2             SE DECISION MADE: 30-SEP-11
BOEBLINGEN    GM D 71034          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DESARA MESH
CALDERA MEDICAL, INC.             510(k) NO: K112609(SPECIAL)
ATTN: VICKI  GAIL                 PHONE NO : 818 879 6555   
5171 CLARETON DRIVE               SE DECISION MADE: 30-SEP-11
AGOURA HILLS CA 91301             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
BIOLITEC MEDICAL DEVICES, INC     510(k) NO: K112442(TRADITIONAL)
ATTN: HARRY  HAYES                PHONE NO : 413 250 0779   
1349 MAIN ROAD                    SE DECISION MADE: 30-SEP-11
GRANVILLE MA 01034                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYNAMIC ECG SYSTEM MODEL TLC5000
CONTEC MEDICAL SYSTEM CO., LTD.   510(k) NO: K101273(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 164 684973
SUITE 5D, NO. 19, LANE 999 ZHONGSHSE DECISION MADE: 30-SEP-11
SHANGHAI    CH 200030             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMAGELINK
COMPUTER PROGRAMS AND SYSTEMS, INC510(k) NO: K112096(ABBREVIATED)
ATTN: MICHAEL  HUNT               PHONE NO : 800 711 2774   
6600 WALL STREET                  SE DECISION MADE: 30-SEP-11
MOBILE AL 36695 4512              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
ANDON MEDICAL CO., LTD.           510(k) NO: K112738(SPECIAL)
ATTN: YI  LIN                     PHONE NO : 86 22 87612426
NO.26 HANGYU RD. TIANJIN AIRPORT ESE DECISION MADE: 30-SEP-11
TIANJIN    CH 300381              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HTS EXTREMITY COIL, HTS SURFACE COIL
TIME MEDICAL SYSTEMS INC          510(k) NO: K112293(ABBREVIATED)
ATTN: JOHN  BABY                  PHONE NO : 852 215 61711
G/F, BIO-INFORMATICS CENTRE NO.2, SE DECISION MADE: 30-SEP-11
SHATIN, N.T., HONG KONG    CH CH  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
HEALTH & LIFE CO., LTD.           510(k) NO: K112320(TRADITIONAL)
ATTN: SARAH  SU                   PHONE NO : 886 282 271300
9F, NO.186, JIAN YI ROAD          SE DECISION MADE: 30-SEP-11
CHUNG HO CITY, TAIPEI    TW 235   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APEX
ELEKTA LIMITED                    510(k) NO: K111676(TRADITIONAL)
ATTN: PATRICK  HULL               PHONE NO : 441 293 544422
LINAC HOUSE, FLEMING WAY          SE DECISION MADE: 30-SEP-11
CRAWLEY    UK RH10 9RR            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K111865(TRADITIONAL)
ATTN: DEBBIE  PEACOCK             PHONE NO : 203 602 3774   
419 WEST AVE.                     SE DECISION MADE: 30-SEP-11
STAMFORD CT 06902 6300            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
BECTON DICKINSON AND COMPANY (BD) 510(k) NO: K111366(TRADITIONAL)
ATTN: RACHEL  LEBLANC             PHONE NO : 801 565 2649   
9450 SOUTH STATE STREET           SE DECISION MADE: 30-SEP-11
SANDY UT 84070                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGISTEER SCISSORS, SURGISTEER DISSECTOR / GRASPER, SURGISTEER HOOK
STEERABLE TECHNOLOGIX             510(k) NO: K111412(TRADITIONAL)
ATTN: GLEN  JORGENSEN             PHONE NO : 904 641 2500   
10302 Deerwood Park Blvd. Ste. 209SE DECISION MADE: 30-SEP-11
Jacksonville FL 32256             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3DI INCLUDING CSCORE
SHINA SYSTEMS LTD.                510(k) NO: K112530(TRADITIONAL)
ATTN: DAN  LAOR                   PHONE NO : 972 482 46632
6 SIRENI                          SE DECISION MADE: 30-SEP-11
HAIFA    IS 32972                 510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   276                                     
                                                 TOTAL WITH SUMMARIES        256                                     
                                                 TOTAL WITH STATEMENTS        20