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U.S. Department of Health and Human Services

Medical Devices

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June 2012 510(k) Clearances

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


DEVICE: STRUCTUR 3
VOCO GMBH                         510(k) NO: K120779(TRADITIONAL)
ATTN: T.  GERKENSMEIER            PHONE NO : 494 721 719200
ANTON-FLETTNER-STRASSE 1-3        SE DECISION MADE: 01-JUN-12
CUXHAVEN    GM D-27472            510(k) STATEMENT

DEVICE: MRSA/SA ELITE MGB
ELITECH                           510(k) NO: K112937(TRADITIONAL)
ATTN: DEBRA K HUTSON              PHONE NO : 425 482 5174   
21720 23RD DRIVE SE, SUITE 150    SE DECISION MADE: 01-JUN-12
BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BORRELIA BURGDORFERI IGM BLOT TEST
GOLD STANDARD DIAGNOSTICS         510(k) NO: K113846(TRADITIONAL)
ATTN: NAPOLEON  MONCE             PHONE NO : 530 759 8000   
2851 SPAFFORD                     SE DECISION MADE: 01-JUN-12
Davis CA 95618                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLLAGEN WOUND DRESSING
DALIM TISSEN CO., LTD.            510(k) NO: K112580(TRADITIONAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114   
325 N PUENTE STREET UNIT B        SE DECISION MADE: 01-JUN-12
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ...
STERNGOLD DENTAL LLC.             510(k) NO: K111798(ABBREVIATED)
ATTN: MARIA  RAO                  PHONE NO : 508 226 5660   
23 FRANK MOSSBERG DR              SE DECISION MADE: 01-JUN-12
ATTLEBORO MA 02703                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS
LIMACORPORATE S.P.A.              510(k) NO: K112900(TRADITIONAL)
ATTN: CHERYL  HASTINGS            PHONE NO : 574 527 4220   
P.O. BOX 696                      SE DECISION MADE: 01-JUN-12
WINONA LAKE IN 46590 696          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT
ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K113438(TRADITIONAL)
ATTN: HYMAN  KATZ                 PHONE NO : 973 852 0158   
4 HENDERSON DRIVE                 SE DECISION MADE: 01-JUN-12
WEST CALDWELL NJ 07006            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VANTAGE TITAN
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K120638(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 730 5000   
2441 MICHELLE DR                  SE DECISION MADE: 01-JUN-12
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS
LIN-ZHI INTERNATIONAL, INC.       510(k) NO: K120763(TRADITIONAL)
ATTN: BERNICE  LIN                PHONE NO : 408 732 3856   
670 Almanor Ave                   SE DECISION MADE: 01-JUN-12
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR
ANDON HEALTH CO.,LTD              510(k) NO: K120672(SPECIAL)
ATTN: THOMAS  BECZE               PHONE NO : 609 951 9596   
116 VILLAGE BOULEVARD SUITE 200   SE DECISION MADE: 01-JUN-12
PRINCETON NJ 08540                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDINAL HEALTH DURABLUE STERILIZATION WRAP
CARDINAL HEALTH-MEDICAL PRODUCTS A510(k) NO: K120542(TRADITIONAL)
ATTN: LAVENIA  FORD               PHONE NO : 847 887 3323   
1430 WAUKEGAN RD.                 SE DECISION MADE: 01-JUN-12
MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: POWERGLIDE MIDLINE CATHETER
C.R. BARD, INC.                   510(k) NO: K121073(TRADITIONAL)
ATTN: JESSICA  AGNELLO            PHONE NO : 801 522 5651   
605 NORTH 5600 WEST               SE DECISION MADE: 01-JUN-12
SALT LAKE CITY UT 84116           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE
THD SPA                           510(k) NO: K121135(TRADITIONAL)
ATTN: GUIDO  BONAPACE             PHONE NO : 393 355 378686
VIA BORGO SANTA CRISTINA 12       SE DECISION MADE: 01-JUN-12
IMOLA    IT 40026                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SR SUITE 1.0
HALIFAX BIOMEDICAL, INC.          510(k) NO: K121345(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 01-JUN-12
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNAPSE 3D NODULE ANALYSIS
FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K120679(TRADITIONAL)
ATTN: JYH-SHYAN  LIN              PHONE NO : 301 251 1092   
419 WEST AVE.                     SE DECISION MADE: 01-JUN-12
STAMFORD CT 06902 6300            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIRTUSO SYSTEM FOR IHC (DO-7)
VENTANA MEDICAL SYSTEMS, INC.     510(k) NO: K121350(TRADITIONAL)
ATTN: ERIKA  AMMIRATI             PHONE NO : 650 949 2768   
575 SHIRLYNN COURT                SE DECISION MADE: 01-JUN-12
LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEANER ROTATIONAL THROMBECTOMY SYSTEM
REX MEDICAL                       510(k) NO: K120346(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 949 706 7456   
55 NORTHERN BLVD. SUITE 200       SE DECISION MADE: 01-JUN-12
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES
MINILAP TECHNOLOGIES              510(k) NO: K113597(TRADITIONAL)
ATTN: ALLAN  ALWARD               PHONE NO : 914 479 5108   
88 ASHFORD AVE                    SE DECISION MADE: 03-JUN-12
DOBBS FERRY NY 10522              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGHT FOR WRINKLES
LED INTELLECTUAL PROPERTIES, LLC  510(k) NO: K120775(TRADITIONAL)
ATTN: STEVE  MARCHESE             PHONE NO : 949 502 4088   
16552 VON KARMAN AVE.             SE DECISION MADE: 04-JUN-12
IRVINE CA 92606                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SNORKEL
FELLMAR COMPANY                   510(k) NO: K112766(TRADITIONAL)
ATTN: WAYNE  MARSHALL             PHONE NO : 212 537 5924   
2670 S MYRTLE AVE. #106           SE DECISION MADE: 04-JUN-12
MONROVIA CA 91016                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS
ZIMMER, INC.                      510(k) NO: K120370(TRADITIONAL)
ATTN: REBECCA  BROOK              PHONE NO : 574 372 4964   
1800 WEST CENTER STREET           SE DECISION MADE: 04-JUN-12
WARSAW IN 46580                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MACH BRACKETS BRIGHT BRACKETS
WORLD BIO TECH CO., LTD           510(k) NO: K120471(TRADITIONAL)
ATTN: PETER  CHUNG                PHONE NO : 412 687 3976   
300 ATWOOD                        SE DECISION MADE: 04-JUN-12
PITTSBURGH PA 15213               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR
STERIS CORPORATION                510(k) NO: K120435(TRADITIONAL)
ATTN: BILL  BRODBECK              PHONE NO : 440 392 7330   
5960 HEISLEY ROAD                 SE DECISION MADE: 04-JUN-12
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRILLIANT SURGICAL K-WIRES
TRILLIANT SURGICAL LTD            510(k) NO: K121008(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
602 Sawyer St. Suite 120          SE DECISION MADE: 04-JUN-12
Houston TX 77007                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S-250 PROTON BEAM RADIATION THERAPY SYSTEM
MEVION MEDICAL SYSTEMS            510(k) NO: K120676(TRADITIONAL)
ATTN: THOMAS H FARIS              PHONE NO : 978 540 1713   
300 FOSTER ST                     SE DECISION MADE: 04-JUN-12
LITTLETON MA 01460                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM
SYNTHES (USA) PRODUCTS LLC        510(k) NO: K120689(TRADITIONAL)
ATTN: THOMAS N SHEA               PHONE NO : 610 719 6809   
1303 Goshen Pkwy                  SE DECISION MADE: 04-JUN-12
West Chester PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CROSSFIX II MEMISCAL REPAIR DEVICE
CAYENNE MEDICAL, INC.             510(k) NO: K121413(SPECIAL)
ATTN: KERESHMEH  SHAHRIARI        PHONE NO : 480 502 3661   
16597 N. 92ND STREET SUITE 101    SE DECISION MADE: 04-JUN-12
SCOTTSDALE AZ 85260               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K121035(TRADITIONAL)
ATTN: GINA  WALLJASPER            PHONE NO : 973 633 5600   
10 HIGH POINT DRIVE               SE DECISION MADE: 04-JUN-12
WAYNE NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: HOMOCYSTEINE TEST
ROCHE                             510(k) NO: K113793(TRADITIONAL)
ATTN: SUSAN  HOLLANDBECK          PHONE NO : 317 521 3380   
9115 HAGUE RD P.O. BOX 50416      SE DECISION MADE: 05-JUN-12
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CITIEFFE-TITANIUM CANNULATED SCREW
CITIEFFE                          510(k) NO: K113388(TRADITIONAL)
ATTN: CLAUDE  BERTHOIN            PHONE NO : 386 672 2630   
110 E. GRANADA BLVD. SUITE 209    SE DECISION MADE: 05-JUN-12
ORMOND BEACH FL 32176             510(k) STATEMENT

DEVICE: ULTIMA NEO
PAIN MANAGEMENT TECHNOLOGIES      510(k) NO: K120054(ABBREVIATED)
ATTN: JOSHUA  LEFKOVITZ           PHONE NO : 330 564 0820   
1340 HOME AVE. , BLDG A           SE DECISION MADE: 05-JUN-12
AKRON OH 44310                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BAUSCH + LOMB NESOFILCON A CONTACT LENS
BAUSCH & LOMB INCORPORATED        510(k) NO: K113703(TRADITIONAL)
ATTN: BARBARA  KLUBE-FALSO        PHONE NO : 585 338 6000   
1400 NORTH GOODMAN ST.            SE DECISION MADE: 05-JUN-12
ROCHESTER NY 14609                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEALEX BIOSPONGE WOUND DRESSING
BIONOVA MEDICAL, INC              510(k) NO: K112191(TRADITIONAL)
ATTN: DEBORAH  LAVOIE GRAYESKI    PHONE NO : 703 562 9800   
901 KING ST SUITE 200             SE DECISION MADE: 05-JUN-12
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM
CYBERSONICS, INC.                 510(k) NO: K120303(ABBREVIATED)
ATTN: LORI  COLVIN                PHONE NO : 814 898 4734   
5325 KUHL RD.                     SE DECISION MADE: 05-JUN-12
Erie PA 16510                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION
I-SENS, INC.                      510(k) NO: K120759(SPECIAL)
ATTN: HYUN  JOON OH               PHONE NO : 822 916 6191
465-6 WOLGYE-DONG, NOWON-GU       SE DECISION MADE: 05-JUN-12
SEOUL    KS 139-845               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRAIN PORT
NICO CORPORATION                  510(k) NO: K120691(TRADITIONAL)
ATTN: JAY  DITTMAN                PHONE NO : 317 660 7118   
9190 Priority Way West Dr Suite 20SE DECISION MADE: 05-JUN-12
Indianapolis IN 46240             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CENTRICITY PACS-IW
GE HEALTHCARE INTEGRATED IT SOLUTI510(k) NO: K121387(SPECIAL)
ATTN: JOHN  MANARIK               PHONE NO : 847 277 5504   
540 W. NW HIGHWAY                 SE DECISION MADE: 05-JUN-12
BARRINGTON IL 60010               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM
SOLTA MEDICAL, INC.               510(k) NO: K121515(SPECIAL)
ATTN: KRISTINE  FOSS              PHONE NO : 510 780 4657   
25881 Industrial Blvd             SE DECISION MADE: 05-JUN-12
HAYWARD CA 94545                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MILLENIUM ANTI-SNORING DEVICE
MILLENIUM DENTAL LABORATORY, INC  510(k) NO: K112627(TRADITIONAL)
ATTN: NGHIEP V NGUYEN             PHONE NO : 763 753 7441   
18056 WACO DRIVE NW               SE DECISION MADE: 06-JUN-12
RAMSEY MN 55303                   510(k) STATEMENT

DEVICE: ADAPTAIN SOLUBLE IMPLANT MATERIAL
CEREMED, INC.                     510(k) NO: K120220(TRADITIONAL)
ATTN: CHELSEA  MITCHELL           PHONE NO : 310 815 2125   
3643 LENAWEE AVE.                 SE DECISION MADE: 06-JUN-12
LOS ANGELES CA 90016              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOCATOR OVERDENTURE IMPLANT SYSTEM
ZEST ANCHORS, LLC                 510(k) NO: K120198(TRADITIONAL)
ATTN: ANNIE  WRIGHT               PHONE NO : 760 743 7744   
2061 Wineridge Pl                 SE DECISION MADE: 06-JUN-12
ESCONDIDO CA 92029                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADHERENT VISUAL STIMULATOR GOGGLES
ANSCHEL TECHNOLOGY, INC.          510(k) NO: K113785(TRADITIONAL)
ATTN: GLEN  PARK                  PHONE NO : 212 681 2100   
261 MADISON AVENUE, 24TH FLOOR    SE DECISION MADE: 06-JUN-12
NEW YORK NY 10016                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDCOMP VASCU-PICC & MIDLINE CATHETERS
MEDICAL COMPONENTS INC            510(k) NO: K121094(SPECIAL)
ATTN: JEAN  CALLOW                PHONE NO : 215 256 4201   
1499 DELP DRIVE                   SE DECISION MADE: 06-JUN-12
HARLEYSVILLE PA 19438             510(k) STATEMENT

DEVICE: ANGIOJET SOLENT DISTA THROMBECTOMY SET
MEDRAD, INC.                      510(k) NO: K113363(TRADITIONAL)
ATTN: MIKE  BURNSIDE              PHONE NO : 763 780 4555   
9055 EVERGREEN BLVD NW            SE DECISION MADE: 06-JUN-12
MINNEAPOLIS MN 55433 8003         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIRCONIA BLANKS (ZIRCOSTAR)
KEROX LTD                         510(k) NO: K120852(ABBREVIATED)
ATTN: SANGRAM  YADAV              PHONE NO : 516 482 9001   
55 NORTHERN BLVD SUITE 200        SE DECISION MADE: 06-JUN-12
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
MAKO SURGICAL CORPORATION         510(k) NO: K121064(SPECIAL)
ATTN: DIONNE  SANDERS             PHONE NO : 954 628 0655   
2555 DAVIE ROAD                   SE DECISION MADE: 06-JUN-12
FORT LAUDERDALE FL 33317          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTIPURPOSE HANDLING MEDIUM
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K121128(TRADITIONAL)
ATTN: JAYME  YAMAGUCHI-OWENS      PHONE NO : 949 261 7800   
2511 DAIMLER ST                   SE DECISION MADE: 06-JUN-12
SANTA ANA CA 92705                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM
STRAUMANN USA                     510(k) NO: K121131(TRADITIONAL)
ATTN: ELAINE  ALAN                PHONE NO : 978 747 2513   
60 MINUTEMAN ROAD                 SE DECISION MADE: 06-JUN-12
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: "AIR LIFT/XEROSTOM" ARTIFICIAL SALIVA
BIOCOSMETICS LABORATORIES         510(k) NO: K120552(TRADITIONAL)
ATTN: RAY  KELLY                  PHONE NO : 203 880 4091   
57 LAZY BROOK RD                  SE DECISION MADE: 06-JUN-12
MONROE CT 06468                   510(k) STATEMENT

DEVICE: DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF
MEDTRONIC INC.                    510(k) NO: K120987(SPECIAL)
ATTN: EMILY  BLUS                 PHONE NO : 763 514 9853   
7611 NORTHLAND DRIVE              SE DECISION MADE: 06-JUN-12
BROOKLYN PARK MN 55428            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K120731(TRADITIONAL)
ATTN: VY  TRAN                    PHONE NO : 650 424 5731   
3100 HANSEN WAY                   SE DECISION MADE: 06-JUN-12
PALO ALTO CA 94304                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROSOFT
PERMA LABORATORIES                510(k) NO: K121318(TRADITIONAL)
ATTN:                             PHONE NO : 
120 Wakefield Run Blvd            SE DECISION MADE: 06-JUN-12
Hinckley OH 44233                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)
ATRICURE, INC.                    510(k) NO: K121507(TRADITIONAL)
ATTN: JAMES  LUCKY                PHONE NO : 513 755 5754   
6217 CENTRE PARK DRIVE            SE DECISION MADE: 06-JUN-12
WEST CHESTER OH 45069             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ARIATELE TELEMETRY TRANSMITTER (96281)
SPACELABS HEALTHCARE              510(k) NO: K121480(SPECIAL)
ATTN: THOMAS  KROENKE             PHONE NO : 303 956 4232   
P.O. BOX 3018                     SE DECISION MADE: 06-JUN-12
NEDERLAND CO 80466                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORA COMFORTSCAN EAR THERMOMETER
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K120712(TRADITIONAL)
ATTN: PINJUNG  CHEN               PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD WUGU DISE DECISION MADE: 06-JUN-12
NEW TAIPEI COUNTY    TW 248       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ...
SPINEVISION, S.A.                 510(k) NO: K112607(TRADITIONAL)
ATTN: DONALD W GUTHNER            PHONE NO : 646 460 2984   
111 HILL ROAD                     SE DECISION MADE: 07-JUN-12
DOUGLASSVILLE PA 19518            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BAHADIR STERILIZATION TRAYS
BAHADIR USA CORP.                 510(k) NO: K112090(ABBREVIATED)
ATTN: ISMAIL  KILIC               PHONE NO : 631 608 8522   
275 WEST HOFFMAN AVENUE           SE DECISION MADE: 07-JUN-12
LINDENHURST NY 11757              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXPORT XT CATHETER, EXPORT AP CATHETER
MEDTRONIC INC.                    510(k) NO: K120808(SPECIAL)
ATTN: ANU  GAUR                   PHONE NO : 978 739 3080   
35-37A CHERRY HILL DRIVE          SE DECISION MADE: 07-JUN-12
DANVERS MA 01923 5186             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPSURE(R) PS SYSTEM
SPINE WAVE, INC.                  510(k) NO: K120646(TRADITIONAL)
ATTN: ROAIDA  RIZKALLAH           PHONE NO : 203 944 9494   
3 ENTERPRISE DR. SUITE 210        SE DECISION MADE: 07-JUN-12
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLAT PANEL DETECTOR
CANON, INC. - MEDICAL EQUPMENT GRO510(k) NO: K121444(SPECIAL)
ATTN: DIANE  RUTHERFORD           PHONE NO : 972 480 9554   
1201 RICHARDSON DR, STE 280       SE DECISION MADE: 07-JUN-12
RICHARDSON TX 75080               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIEWFLEX XTRA ICE CATHETER
ST. JUDE MEDICAL                  510(k) NO: K121381(SPECIAL)
ATTN: LOUCINDA  BJORKLUND         PHONE NO : 651 756 3230   
ONE ST. JUDE MEDICAL DRIVE        SE DECISION MADE: 07-JUN-12
ST. PAUL MN 55117                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR
KFX MEDICAL                       510(k) NO: K120841(SPECIAL)
ATTN: GAYLE  HIROTA               PHONE NO : 760 444 8844   
5845 Avenida Encinas, Suite 128   SE DECISION MADE: 07-JUN-12
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
SMITH & NEPHEW, INC.              510(k) NO: K120871(TRADITIONAL)
ATTN: GINO  ROUSS                 PHONE NO : 901 399 6707   
1450 BROOKS RD.                   SE DECISION MADE: 07-JUN-12
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LANO-E
UG GLOBAL RESOURCES SDN BHD       510(k) NO: K111604(TRADITIONAL)
ATTN: KENNETH  STANTON            PHONE NO : 714 444 2248   
1565 SUNFLOWER AVE.               SE DECISION MADE: 08-JUN-12
COSTA MESA CA 92626               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LANO-E
UG GLOBAL RESOURCES SDN BHD       510(k) NO: K111718(TRADITIONAL)
ATTN: KENNETH  STANTON            PHONE NO : 714 444 2248   
1565 SUNFLOWER AVE.               SE DECISION MADE: 08-JUN-12
COSTA MESA CA 92626               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIVA EB
ETVIEW LTD.                       510(k) NO: K120334(TRADITIONAL)
ATTN: YORAM  LEVY                 PHONE NO : 972 463 88837
31 HAAVODA ST.                    SE DECISION MADE: 08-JUN-12
BINYAMINA    IS 30500             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER
COLOPLAST A/S                     510(k) NO: K112860(TRADITIONAL)
ATTN: BRIAN  SCHMIDT              PHONE NO : 612 302 4987   
1601 WEST RIVER ROAD NORTH        SE DECISION MADE: 08-JUN-12
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EARLYSENSE (EVERON) SYSTEM
EARLYSENSE LTD.                   510(k) NO: K120465(TRADITIONAL)
ATTN: DALIA  ARGAMAN              PHONE NO : 972 752 2330
12 TZVI STREET                    SE DECISION MADE: 08-JUN-12
RAMAT GAN    IS 52504             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
ANGIOSLIDE, LTD                   510(k) NO: K120164(TRADITIONAL)
ATTN: CLAY  ANSELMO               PHONE NO : 303 223 4303   
11925 W. I-70 FRONTAGE RD NORTH, SSE DECISION MADE: 08-JUN-12
WHEAT RIDGE CO 80033              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIPAL
WATERMARK MEDICAL                 510(k) NO: K120470(TRADITIONAL)
ATTN: MICHAEL J LEIGH             PHONE NO : 262 957 6797   
12715 FALCON DRIVE                SE DECISION MADE: 08-JUN-12
BROOKFIELD WI 53005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TELIO CS CEM IMPLANT
IVOCLAR VIVADENT AG               510(k) NO: K120432(TRADITIONAL)
ATTN: DONNA MARIE  HARTNETT       PHONE NO : 716 691 2260   
175 PINEVIEW DR.                  SE DECISION MADE: 08-JUN-12
AMHERST NY 14228                  510(k) STATEMENT

DEVICE: TBD
LENSAR, INC.                      510(k) NO: K120214(TRADITIONAL)
ATTN: SHIRLEY  MCGARVEY           PHONE NO : 702 524 3701   
2800 DISCOVERY DRIVE SUITE 100    SE DECISION MADE: 08-JUN-12
ORLANDO FL 32826                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
ELEAM MEDICAL A.C.A.L             510(k) NO: K120624(TRADITIONAL)
ATTN: AHARON  COHEN               PHONE NO : 972 469 88120
M.P. MEROM HA'GALIL               SE DECISION MADE: 08-JUN-12
KIBBUTZ BARAM    IS 13860         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TUFF-TEMP 2.0
PULPDENT CORPORATION              510(k) NO: K120784(TRADITIONAL)
ATTN: KENNETH J BERK              PHONE NO : 617 926 6666   
80 Oakland St                     SE DECISION MADE: 08-JUN-12
WATERTOWN MA 02472                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GMK - LINE EXTENSION
MEDACTA INTERNATIONAL             510(k) NO: K120790(SPECIAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 437 7085   
4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 08-JUN-12
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMISTEM AND QUADRA - LINE EXTENSION
MEDACTA INTERNATIONAL             510(k) NO: K121011(SPECIAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 437 7085   
4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 08-JUN-12
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GIRAFFE BLUE SPOT PT LITE
LUMITEX, INC.                     510(k) NO: K120820(TRADITIONAL)
ATTN: DAVID  FELTY                PHONE NO : 440 243 8401   
8443 DOW CIR.                     SE DECISION MADE: 08-JUN-12
STRONGSVILLE OH 44136             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BELLYBOARD, SBRT ACCESSORIES
MEDTEC INC. DBA CIVCO MEDICAL SOLU510(k) NO: K121545(TRADITIONAL)
ATTN: AMANDA  STAHLE              PHONE NO : 319 248 6628   
1401 8TH STREET SE                SE DECISION MADE: 08-JUN-12
ORANGE CITY IA 51041              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Q-FLO CLOSED MALE LUER CONNECTOR
INFUSION INNOVATIONS, INC.        510(k) NO: K121554(TRADITIONAL)
ATTN: BABAK  NEMATI               PHONE NO : 858 456 6116   
7514 GIRARD AVENUE                SE DECISION MADE: 08-JUN-12
LAJOLLA CA 92037                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TRANSPORT CULTURE MEDIUM DEVICE
PURITAN MEDICAL PRODUCTS LLC      510(k) NO: K120846(TRADITIONAL)
ATTN: MEHDI  KARAMCHI             PHONE NO : 207 876 3311   
31 SCHOOL STREET P.O. BOX 149     SE DECISION MADE: 08-JUN-12
GUILFORD ME 04443                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SCENIUM 2.0
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K121074(TRADITIONAL)
ATTN: ELAINE  CHANG               PHONE NO : 865 218 2873   
810 INNOVATION DR.                SE DECISION MADE: 08-JUN-12
KNOXVILLE TN 37932                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PAX-FLEX3D, PHT-7000
VATECH CO., LTD.                  510(k) NO: K121412(SPECIAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
12946 KIMBERLEY LN                SE DECISION MADE: 08-JUN-12
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018'" G
TRIREME MEDICAL, INC.             510(k) NO: K121402(SPECIAL)
ATTN: SHIVA  ARDAKANI             PHONE NO : 925 931 1300   
7060 Koll Center Parkway Suite 300SE DECISION MADE: 08-JUN-12
Pleasanton CA 94566               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AERODR STITCHING SYSTEM
KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K120752(TRADITIONAL)
ATTN: RUSSEL  MUNVES              PHONE NO : 212 497 8208   
140 EAST 45TH ST., 25TH FLOOR TWO SE DECISION MADE: 08-JUN-12
NEW YORK NY 10017                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIMUPLAN TREATMENT PLANNING SYSTEM
SIMUPLAN S.L.                     510(k) NO: K120551(TRADITIONAL)
ATTN: LU ANNE  JOHNSON            PHONE NO : 715 403 5321   
1917 29 3/4 AVE                   SE DECISION MADE: 08-JUN-12
RICE LAKE WI 54868                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K113411(TRADITIONAL)
ATTN: DANNETTE  CROOMS            PHONE NO : 801 565 6209   
12050 LONE PEAK PKWY              SE DECISION MADE: 11-JUN-12
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTISYN Y-SHAPED MESH
ETHICON, INC.                     510(k) NO: K113205(TRADITIONAL)
ATTN: SARAH  MCMANUS              PHONE NO : 908 218 2954   
ROUTE 22 WEST P.O. BOX 151        SE DECISION MADE: 11-JUN-12
SOMERVILLE NJ 08876 0151          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE ADHESIVE SURFACE ELECTRODE
SPES MEDICA S.R.L.                510(k) NO: K120494(TRADITIONAL)
ATTN: ALFREDO  SPADAVECHIA        PHONE NO : 390 828 614191
VIA EUROPA-ZONA INDUSTRIALE       SE DECISION MADE: 11-JUN-12
BATTIPAGLIA    IT 84091           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EPLUS SKIN TREATMENT SYSTEM
SYNERON, LTD.                     510(k) NO: K113868(TRADITIONAL)
ATTN: YORAM  LEVY                 PHONE NO : 972 463888 37
31 HAAVODA ST.                    SE DECISION MADE: 11-JUN-12
BINYAMINA    IS 30500             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER QUIKFLAP STERILE PROCEDURE PACK
STRYKER                           510(k) NO: K120352(SPECIAL)
ATTN: JAMSHED  BADARPURA          PHONE NO : 269 389 4260   
750 TRADE CENTER WAY STE 200      SE DECISION MADE: 11-JUN-12
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEPUT DELTA XTEND REVERSE SHOULDER
DEPUY FRANCE                      510(k) NO: K120174(TRADITIONAL)
ATTN: MEGAN  BURNS                PHONE NO : 574 372 7745   
700 ORTHOPAEDIC DRIVE             SE DECISION MADE: 11-JUN-12
WARSAW IN 46580                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLEASE700/900 SERIES VENTILATORS
SPACELABS HEALTHCARE              510(k) NO: K112729(TRADITIONAL)
ATTN: THOMAS  KROENKE             PHONE NO : 303 956 4232   
P.O. BOX 3018                     SE DECISION MADE: 11-JUN-12
NEDERLAND CO 80466                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PURESLEEP
SLEEP SCIENCE PARTNERS, INC.      510(k) NO: K113022(TRADITIONAL)
ATTN: HEATHER  FLICK              PHONE NO : 415 272 7777   
900 Larkspur Landing Circle Suite SE DECISION MADE: 11-JUN-12
Larkspur CA 94939                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REPROCESSED ENDOSCOPIC TROCARS
STERILMED, INC.                   510(k) NO: K121240(TRADITIONAL)
ATTN: JASON  SKRAMSTED, RAC       PHONE NO : 763 488 3483   
11400 73RD AVE. NORTH             SE DECISION MADE: 11-JUN-12
MAPLE GROVE MN 55369              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODULTH SLK
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K120769(SPECIAL)
ATTN: LEIGH  SPOTTEN              PHONE NO : 424 218 8738   
2151 E. GRAND AVE.                SE DECISION MADE: 12-JUN-12
EL SEGUNDO CA 90245               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV
EXACT MEDICAL MANUFACTURING, INC  510(k) NO: K120045(TRADITIONAL)
ATTN: ROBERT O DEAN               PHONE NO : 716 440 7362   
1083 DELAWARE AVE                 SE DECISION MADE: 12-JUN-12
BUFFALO NY 14209                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES
CATHETER ROBOTICS INC             510(k) NO: K113628(TRADITIONAL)
ATTN: JENNIFER  ENGLUND           PHONE NO : 973 691 2000   
500 INTERNATIONAL DRIVE           SE DECISION MADE: 12-JUN-12
MOUNT OLIVE NJ 07828              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMPLATZER VASCULAR PLUG 4
AGA MEDICAL CORP.                 510(k) NO: K113658(TRADITIONAL)
ATTN: SHERRY  KOLLMANN            PHONE NO : 651 756 5463   
5050 NATHAN LANE NORTH            SE DECISION MADE: 12-JUN-12
PLYMOUTH MN 55442                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MACROLYTE DISPERSIVE ELECTRODE
CONMED CORPORATION                510(k) NO: K120476(SPECIAL)
ATTN: SHAWN  RIEDEL               PHONE NO : 303 268 8224   
14603 E. FREMONT AVE.             SE DECISION MADE: 12-JUN-12
CENTENNIAL CO 80112               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERILE DISPOSABLES FOR MER
ALPHA OMEGA ENGINEERING, LTD.     510(k) NO: K120098(TRADITIONAL)
ATTN: ILAN  SHARON                PHONE NO : 972 528 704904
1 HA'RAKEFET ST., P.O BOX 4262    SE DECISION MADE: 12-JUN-12
ZICHRON YAACOV    IS 30900        510(k) STATEMENT

DEVICE: NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE
ZIMMER GMBH                       510(k) NO: K120772(TRADITIONAL)
ATTN: ROMIL  SHETH                PHONE NO : 574 371 1621   
P.O. BOX 708                      SE DECISION MADE: 12-JUN-12
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISCOVERY CT750 HD
GE MEDICAL SYSTEMS, LLC           510(k) NO: K120833(SPECIAL)
ATTN: JOHN  JAECKLE               PHONE NO : 262 424 9547   
3000 N GRANDVIEW BLVD.            SE DECISION MADE: 12-JUN-12
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONMED SUREFIT DUAL DISPERSIVE ELECTRODE
CONMED CORPORATION                510(k) NO: K120322(SPECIAL)
ATTN: SHAWN  RIEDEL               PHONE NO : 303 268 8224   
14603 E. FREMONT AVE.             SE DECISION MADE: 12-JUN-12
CENTENNIAL CO 80112               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LITECURE THERAPY COMPACT
LITECURE, LLC                     510(k) NO: K121487(SPECIAL)
ATTN: LIANG  LU                   PHONE NO : 302 709 0408   
250 Corporate Blvd. Suite B       SE DECISION MADE: 12-JUN-12
NEWARK DE 19702                   510(k) STATEMENT

DEVICE: MULTIARRAY KIT
PARAMED SRL                       510(k) NO: K121249(SPECIAL)
ATTN: LUISELLA  DE BENEDETTI      PHONE NO : 390 106489 358
CORSO PERRONE 73R                 SE DECISION MADE: 12-JUN-12
GENOVA    IT 16152                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RENU MEDICAL RSPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME
RENU MEDICAL, INC.                510(k) NO: K121145(TRADITIONAL)
ATTN: BRUCE  PIERSON              PHONE NO : 425 353 1110   
9800 EVERGREEN WAY                SE DECISION MADE: 12-JUN-12
EVERETT WA 98204                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AGILITY
ELEKTA LTD.                       510(k) NO: K121328(TRADITIONAL)
ATTN: PATRICK  HULL               PHONE NO : 441 293 654165
FLEMING WAY LINAC HOUSE           SE DECISION MADE: 12-JUN-12
CRAWLEY, WEST SUSSEX    UK RH10 9R510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INVENT SNORING DEVICE
VENTUS MEDICAL, INC.              510(k) NO: K120665(TRADITIONAL)
ATTN: CINDY  DOMECUS              PHONE NO : 650 343 4813   
1171 BARROILHET DRIVE             SE DECISION MADE: 12-JUN-12
HILLSBOROUGH CA 94010             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT
DENTIST IN A BOX PTY. LTD         510(k) NO: K120695(TRADITIONAL)
ATTN: JOHN  BANKY                 PHONE NO : 613 952 85388
44 HORACE ST                      SE DECISION MADE: 12-JUN-12
MALVERN, VICTORIA    AS 3144      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONIXGPS NEEDLE SENSOR
ULTRASONIX MEDICAL CORPORATION    510(k) NO: K111818(TRADITIONAL)
ATTN: CHAS  YU                    PHONE NO : 604 279 8550
130-4311 VIKING WAY               SE DECISION MADE: 13-JUN-12
RICHMOND, BRITISH COLUMBIA    CA V510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: HONOUR SPACER SYSTEM
NEXXT SPINE LLC                   510(k) NO: K120345(TRADITIONAL)
ATTN: KAREN E WARDEN              PHONE NO : 440 729 8457   
PO BOX 566                        SE DECISION MADE: 13-JUN-12
CHESTERLAND OH 44026              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS
RENOVIS SURGICAL TECHNOLOGIES, LLC510(k) NO: K112897(TRADITIONAL)
ATTN: DAVID A TEICHER             PHONE NO : 612 338 7170   
825 NICOLLET MALL STE 1820        SE DECISION MADE: 13-JUN-12
MINNEAPOLIS MN 55402              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PARIETEX COMPOSITE VENTRAL PATCH
SOFRADIM PRODUCTION               510(k) NO: K120506(TRADITIONAL)
ATTN: JAMES  MCMAHON              PHONE NO : 781 839 1787   
15 CROSBY DR                      SE DECISION MADE: 13-JUN-12
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONCIERGE GUIDING CATHETER
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K121051(SPECIAL)
ATTN: MICHAELA  RIVKOWICH         PHONE NO : 801 208 4196   
1600 WEST MERIT PKWY.             SE DECISION MADE: 13-JUN-12
South Jordan UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
SPINEOLOGY, INC.                  510(k) NO: K121129(SPECIAL)
ATTN: BRYAN  BECKER               PHONE NO : 651 256 8500   
7800 3RD ST N., SUITE 600         SE DECISION MADE: 13-JUN-12
ST. PAUL MN 55128                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DURABLUE STERILIZATION WRAP
CARDINAL HEALTH 200, LLC          510(k) NO: K120658(TRADITIONAL)
ATTN: LAVENIA  FORD               PHONE NO : 847 887 3323   
1430 WAUKEGAN ROAD                SE DECISION MADE: 13-JUN-12
WAUKEGAN IL 60085                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINI MAXLOCK EXTREME PLATING SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K121437(SPECIAL)
ATTN: DEREK  LEWIS                PHONE NO : 330 869 9562   
1065 Medina Rd. SUITE 500         SE DECISION MADE: 13-JUN-12
Medina OH 44256                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQUILION PREMIUM
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K120546(SPECIAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 MICHELLE DR                  SE DECISION MADE: 13-JUN-12
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TUBECLEAR
ACTUATED MEDICAL, INC             510(k) NO: K121571(TRADITIONAL)
ATTN: DEBORA  DEMERS              PHONE NO : 814 355 0003   
310 ROLLING RIDGE DR              SE DECISION MADE: 13-JUN-12
BELLEFONTE PA 16823               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: EXPRESSION INFORMATION PORTAL
INVIVO CORPORATION                510(k) NO: K121424(SPECIAL)
ATTN: RUSTY  KELLY                PHONE NO : 407 455 6166   
12151 RESEARCH PKWY               SE DECISION MADE: 13-JUN-12
ORLANDO FL 32826                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDART 620
MEDART A/S                        510(k) NO: K120573(SPECIAL)
ATTN: DARREN  THOMAS              PHONE NO : 441 792 798768
2, PARK PAVILIONS, CLOS LLYN CWM, SE DECISION MADE: 13-JUN-12
SWANSEA    UK SA6 8QY             510(k) STATEMENT

DEVICE: SYNTHES SCOUT TACK FIXATION
SYNTHES SPINE                     510(k) NO: K111048(TRADITIONAL)
ATTN: HEATHER  GUERIN             PHONE NO : 610 719 5432   
1302 WRIGHTS LN EAST              SE DECISION MADE: 14-JUN-12
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE
MEDTRONIC INC.                    510(k) NO: K121451(SPECIAL)
ATTN: MARY  DONLIN                PHONE NO : 763 526 9172   
8200 CORAL SEA STREET NE          SE DECISION MADE: 14-JUN-12
MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRASONIC SURGERY MACHINE
DMETEC CO., LTD.                  510(k) NO: K113152(TRADITIONAL)
ATTN: DANIEL  NAM                 PHONE NO : 213 626 1544   
1415-1441 GARDENA AVE.            SE DECISION MADE: 14-JUN-12
GLENDALE CA 91204                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM
DEPUY SPINE, INC.                 510(k) NO: K111136(TRADITIONAL)
ATTN: FRANK  JURCZAK              PHONE NO : 508 828 3288   
325 PARAMOUNT DR.                 SE DECISION MADE: 14-JUN-12
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVERE 4.5 STABILIZATION SYSTEM
GLOBE MEDICAL, INC.               510(k) NO: K113395(TRADITIONAL)
ATTN: SARAH M FITZGERALD          PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 14-JUN-12
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KODAMA INTRAVASCULAR ULRASOUND CATHETER
SILICON VALLY MEDICAL INSTRUMENTS,510(k) NO: K113008(TRADITIONAL)
ATTN: RICHARD E ANDERSON          PHONE NO : 510 897 4695   
47697 WESTINGHOUSE SUITE 101      SE DECISION MADE: 14-JUN-12
FREMONT CA 94539                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUSION FLAT PANEL
ICRCO INC.                        510(k) NO: K113449(TRADITIONAL)
ATTN: GREG  WACHTLER              PHONE NO : 310 921 9559   
2580 WEST 237TH STREET            SE DECISION MADE: 14-JUN-12
TORRANCE CA 90505                 510(k) STATEMENT

DEVICE: OBIX PERINATAL DATA SYSTEM 7.0
CLINICAL COMPUTER SYSTEMS, INC.   510(k) NO: K121208(TRADITIONAL)
ATTN: CYNTHIA  BELL               PHONE NO : 877 937 6249   
715 TOLLGATE RD. UNIT H           SE DECISION MADE: 14-JUN-12
ELGIN IL 60123 9331               510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: CHISON DIAGNOSTIC ULTRASOUND SYSTEM
CHISON MEDICAL IMAGING CO., LTD.  510(k) NO: K120801(TRADITIONAL)
ATTN: BOB  LEIKER                 PHONE NO : 925 556 1302   
7263 CRONIN CIRCLE                SE DECISION MADE: 14-JUN-12
DUBLIN CA 94568                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K120648(TRADITIONAL)
ATTN: JYH-SHYAN  LIN              PHONE NO : 301 251 1092   
419 WEST AVE.                     SE DECISION MADE: 14-JUN-12
STAMFORD CT 06902 6300            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
CORDIS CORPORATION                510(k) NO: K121442(SPECIAL)
ATTN: DONNA  MARSHALL             PHONE NO : 908 541 4781   
430 RT. 22 EAST                   SE DECISION MADE: 14-JUN-12
BRIDGEWATER NJ 08807              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUREFIRE HI-FLOW MICROCATHETER
SUREFIRE MEDICAL, INC.            510(k) NO: K121677(TRADITIONAL)
ATTN: MARIO  ARBESU               PHONE NO : 305 378 2651   
12415 SW 136 Avenue Unit 3        SE DECISION MADE: 14-JUN-12
Miami FL 33186                    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VECTOR
R4 VASCULAR, INC.                 510(k) NO: K121385(TRADITIONAL)
ATTN: MICHAEL  HOCH               PHONE NO : 763 494 8400   
7550 MERIDIAN CIRCLE SUITE 150    SE DECISION MADE: 14-JUN-12
MAPLE GROVE MN 55369              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR
ANDON HEALTH CO., LTD             510(k) NO: K121470(SPECIAL)
ATTN: LIU  YI                     PHONE NO : 86 22 60526161
No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 14-JUN-12
TIANJIN    CN 300190              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFINITI(R) VISION SYSTEM
ALCON MANUFACTURING, LTD.         510(k) NO: K120912(TRADITIONAL)
ATTN: MARTIN A KAUFMAN            PHONE NO : 949 753 6250   
15800 ALTON PKWY.                 SE DECISION MADE: 15-JUN-12
IRVINE CA 92618 3818              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIGNATURE PLANNER,SIGNATURE GUIDES
MATERIALISE N.V.                  510(k) NO: K111863(TRADITIONAL)
ATTN: ALAXANDRA  RAZZHIVINA       PHONE NO : 321 639 6280
15 TECHNOLOGIELAAN                SE DECISION MADE: 15-JUN-12
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IVENT101
VERSAMED MEDICAL SYSTEMS LTD.     510(k) NO: K112754(TRADITIONAL)
ATTN: SHLOMI  DELER               PHONE NO : 972 989 15407
HASHARON INDUSTRIAL PARK ORNAT BLDSE DECISION MADE: 15-JUN-12
KADIMA    IS 60920                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: READY VIEW
GE HEALTHCARE (GE MEDICAL SYSTEMS 510(k) NO: K113456(SPECIAL)
ATTN: ELIZABETH  MATHEW           PHONE NO : 262 424 7774   
3144 N GRANDVIEW BLVD, MAIL STOP- SE DECISION MADE: 15-JUN-12
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TM-400 DEVICE
ZIMMER TRABECULAR METAL TECHNOLOGY510(k) NO: K120203(TRADITIONAL)
ATTN: KATHLEEN  RUTHERFORD        PHONE NO : 973 576 0139   
10 POMEROY RD.                    SE DECISION MADE: 15-JUN-12
Parsippany NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUDIT MICROLQ SPINAL FLUID CONTROL
AALTO SCIENTIFIC LTD.             510(k) NO: K112742(TRADITIONAL)
ATTN: DESSI  LYAKOV               PHONE NO : 760 431 6942   
1959 KELLOGG AVE.                 SE DECISION MADE: 15-JUN-12
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM
SHANTOU INSTITUTE OF ULTRASONIC IN510(k) NO: K113613(TRADITIONAL)
ATTN: FLOWER  CAI                 PHONE NO : 867 548 8250150
77 JINSHA RD.                     SE DECISION MADE: 15-JUN-12
SHANTOU, SEZ    CH 515041         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS
BIOMET SPINE                      510(k) NO: K121130(SPECIAL)
ATTN: VIVIAN  KELLY               PHONE NO : 973 299 9300   
100 INTERPACE PARKWAY             SE DECISION MADE: 15-JUN-12
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORA COMFORTSCAN EAR THERMOMETER
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K121118(TRADITIONAL)
ATTN: PINJUNG  CHEN               PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD WUGU DISE DECISION MADE: 15-JUN-12
NEW TAIPEI    TW 24888            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DURAGEN SECURE DURAL REGNERATION MATRIX
INTEGRA LIFESCIENCES              510(k) NO: K120600(TRADITIONAL)
ATTN: AAKASH  JAIN                PHONE NO : 609 936 5526   
311 ENTERPRISE DR.                SE DECISION MADE: 15-JUN-12
PLAINSBORO NJ 08536               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET
TOSOH BIOSCIENCE, INC.            510(k) NO: K121533(TRADITIONAL)
ATTN: ROBERT  WICK                PHONE NO : 650 636 8117   
6000 SHORELINE COURT SUITE 101    SE DECISION MADE: 15-JUN-12
SOUTH SAN FRANCISCO CA 94080      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K120823(TRADITIONAL)
ATTN: DENISE  OPPERMANN           PHONE NO : 781 699 4479   
920 WINTER STREET                 SE DECISION MADE: 15-JUN-12
WALTHAM MA 02451 1457             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 1.5T 16CH FLEX SPEEDER LARGE
NEOCOIL, LLC                      510(k) NO: K121362(TRADITIONAL)
ATTN: STEVEN  NICHOLS             PHONE NO : 262 347 1250   
N27 W23910A PAUL RD.              SE DECISION MADE: 15-JUN-12
PEWAUKEE WI 53072                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDYSSY LT CAGE SYSTEM
MEDYSSEY CO., LTD.                510(k) NO: K121246(SPECIAL)
ATTN: MICHAEL  KVITNISKY          PHONE NO : 847 982 0100   
8001 N. LINCOLN AVE               SE DECISION MADE: 15-JUN-12
SKOKIE IL 60077                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GREENLIGHT MOXY FIBER OPTIC
AMERICAN MEDICAL SYSTEMS          510(k) NO: K120870(SPECIAL)
ATTN: DOREEN  NAKAMURA            PHONE NO : 408 456 3441   
3070 ORCHARD DRIVE                SE DECISION MADE: 15-JUN-12
SAN JOSE CA 95134                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEAUTICEM SA
SHOFU DENTAL CORPORATION          510(k) NO: K120159(TRADITIONAL)
ATTN: DAVID P MORAIS              PHONE NO : 760 736 3277   
1225 STONE DRIVE                  SE DECISION MADE: 18-JUN-12
SAN MARCOS CA 92078               510(k) STATEMENT

DEVICE: ALPHA ORTHOPAEDICS AT2 SYSTEM
ALPHA ORTHOPAEDICS, INC           510(k) NO: K120527(TRADITIONAL)
ATTN: GINA  TO                    PHONE NO : 510 969 7323   
7700 ADGEWATER DRIVE SUITE # 405  SE DECISION MADE: 18-JUN-12
OAKLAND CA 94621                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES VA LCP ANKLE TRAUMA SYSTEM
SYNTHES USA                       510(k) NO: K120854(TRADITIONAL)
ATTN: ANGELA F LASSANDRO          PHONE NO : 610 719 6854   
1301 GOSHEN PKWY                  SE DECISION MADE: 18-JUN-12
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL
GE MEDICAL SYSTEMS SCS            510(k) NO: K120910(SPECIAL)
ATTN: STEPHEN  SLAVENS            PHONE NO : 262 548 4992
283, RUE DE LA MINIERE            SE DECISION MADE: 18-JUN-12
BUC    FR 78530                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CIRRUS PHOTO
CARL ZEISS MEDITEC INC            510(k) NO: K112184(TRADITIONAL)
ATTN: JUDITH A BRIMACOMBE         PHONE NO : 925 557 4616   
5160 HACIENDA DR.                 SE DECISION MADE: 18-JUN-12
DUBLIN CA 94568                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MATRIXBRUSH ENDOMETRIAL SAMPLER
POST OAK INNOVATIONS, INC.        510(k) NO: K112763(TRADITIONAL)
ATTN: HEATHER  CRAWFORD           PHONE NO : 512 328 9404   
9433 BEE CAVES ROAD BUILDING 1, SUSE DECISION MADE: 18-JUN-12
AUSTIN TX 78733                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CMI IMPLANT IS II ACTIVE
NEOBIOTECH CO., LTD.              510(k) NO: K120503(TRADITIONAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114   
325 N PUENTE ST. UNIT B           SE DECISION MADE: 18-JUN-12
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
SYNTHES USA, LLC                  510(k) NO: K112030(TRADITIONAL)
ATTN: ANGELA F LASSANDRO          PHONE NO : 610 719 6854   
1301 GOSHEN PARKWAY               SE DECISION MADE: 19-JUN-12
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: I-ROOT 100
S-DENTI CO., LTD.                 510(k) NO: K112508(TRADITIONAL)
ATTN: TAE K NAM                   PHONE NO : 822 262 737657
VALLEY 6,481-4 GASAN-DONG GEUMCHEOSE DECISION MADE: 19-JUN-12
TAE KYE NAM    KS 153-803         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML
NEPHRON PHARMACEUTICALS CORP.     510(k) NO: K113033(TRADITIONAL)
ATTN: MARCUS  JULIANO             PHONE NO : 407 246 1389   
4121 34TH ST. S.W.                SE DECISION MADE: 19-JUN-12
ORLANDO FL 32811 6475             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEALITE II SYSTEM
LUTRONIC CORPORATION              510(k) NO: K113668(TRADITIONAL)
ATTN: JHUNG WON  VOJIR            PHONE NO : 215 205 2219   
6 NESHAMINY INTERPLEX, SUITE 207  SE DECISION MADE: 19-JUN-12
TREVOSE PA 19053                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT
CHURCH & DWIGHT CO., INC.         510(k) NO: K120286(TRADITIONAL)
ATTN: JOSEPH  CICCONE             PHONE NO : 609 497 7251   
469 NORTH HARRISON ST.            SE DECISION MADE: 19-JUN-12
PRINCETON NJ 08543 5297           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROEEG SYSTEM
BIO-SIGNAL GROUP CORPORATION      510(k) NO: K112817(TRADITIONAL)
ATTN: ANDERSON  MICU              PHONE NO : 718 928 7076   
760 PARKSIDE AVE                  SE DECISION MADE: 19-JUN-12
BROOKLYN NY 11226                 510(k) STATEMENT

DEVICE: LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8;
ENCORE MEDICAL, L.P.              510(k) NO: K121024(TRADITIONAL)
ATTN: WILLIAM  GARZON             PHONE NO : 512 834 6391   
9800 METRIC BLVD.                 SE DECISION MADE: 19-JUN-12
AUSTIN TX 78758                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OP SPINE SYSTEM
ORTHOPEDIATRICS, CORP.            510(k) NO: K121250(SPECIAL)
ATTN: MARK  FOX                   PHONE NO : 574 268 6379   
2850 FRONTIER DRIVE               SE DECISION MADE: 19-JUN-12
WARSAW IN 46582                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOGATER AVANTAGE CO2 INSUFFLATOR
BYRNE MEDICAL, INC.               510(k) NO: K113310(TRADITIONAL)
ATTN: BRENT  GEIGER               PHONE NO : 763 553 3345   
14605 28TH AVENUE NORTH           SE DECISION MADE: 20-JUN-12
MINNEAPOLIS MN 55442              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES
OLYMPUS WINTER & IBE GMBH         510(k) NO: K120418(SPECIAL)
ATTN: SHERI  MUSGNUNG             PHONE NO : 484 896 5405   
3500 CORPORATE PKWAY PO BOX 610   SE DECISION MADE: 20-JUN-12
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLUE MOUNTAIN CERVICAL PLATE
QUALGENIX LLC                     510(k) NO: K112809(TRADITIONAL)
ATTN: RICHARD  DESLAURIERS        PHONE NO : 203 262 9340   
1 JACK'S HILL ROAD UNIT 3E        SE DECISION MADE: 20-JUN-12
OXFORD CT 06478                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S
DRFP LTD.                         510(k) NO: K120048(TRADITIONAL)
ATTN: DAGMAR  MAESER              PHONE NO : 31 20 4289591
AMSTEL 320-I                      SE DECISION MADE: 20-JUN-12
AMSTERDAM    UK 1017 AP           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TI-MAX X450
NAKANISHI, INC.                   510(k) NO: K112024(TRADITIONAL)
ATTN: DIANE  RUTHERFORD           PHONE NO : 972 480 9554   
1201 RICHARDSON DRIVE SUITE 280   SE DECISION MADE: 20-JUN-12
RICHARDSON TX 75080               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: X4
ADVANCED BRAIN MONITORING, INC.   510(k) NO: K120447(TRADITIONAL)
ATTN: ADRIENNE  LENZ              PHONE NO : 262 290 0023   
W324 S3649 COUNTY RD E            SE DECISION MADE: 20-JUN-12
DOUSMAN WI 53118                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BODYFIX SYSTEM
MEDICAL INTELLIGENCE MEDIZINTECHNI510(k) NO: K121530(TRADITIONAL)
ATTN: MICHAEL  WOLFF              PHONE NO : 49 823 296920
Robert-Bosch-Strasse 8            SE DECISION MADE: 20-JUN-12
SCHWABMUENCHEN    DE 86830        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONE-TROL HEMOGLOBIN A1C CONTROL SET
CONE BIOPRODUCTS                  510(k) NO: K121534(TRADITIONAL)
ATTN: GAIL  SCHIEVELBEIN          PHONE NO : 830 379 0197   
1012 N. AUSTIN ST.                SE DECISION MADE: 20-JUN-12
SEGUIN TX 78155                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET
TELEFLEX, INC.                    510(k) NO: K121403(SPECIAL)
ATTN: PAUL  AMUDALA               PHONE NO : 610 378 0131   
2400 BERNVILLE ROAD               SE DECISION MADE: 20-JUN-12
READING PA 19605                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QFIX RADIOTHERAPY CHAIR
WFR/AQUAPLAST CORP.               510(k) NO: K120916(TRADITIONAL)
ATTN: TIM  WADE                   PHONE NO : 610 268 0585   
440 CHURCH ROAD                   SE DECISION MADE: 20-JUN-12
Avondale PA 19311                 510(k) STATEMENT

DEVICE: ABLE-X
IM-ABLE LTD                       510(k) NO: K120783(TRADITIONAL)
ATTN: SIGI  CARON                 PHONE NO : 310 377 3069   
2400 VIA CARILLO                  SE DECISION MADE: 20-JUN-12
PALOS VERDES ESTATES CA 90274     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E.G. SCAN II ESPHAGOSCOPE SYSTEM
INTROMEDIC CO., LTD               510(k) NO: K120702(TRADITIONAL)
ATTN: JIN YOUNG  LEE              PHONE NO : 822 801 9300
SUITE 1104 E&C VENTURE DREAM TOWERSE DECISION MADE: 20-JUN-12
GURO-GU , SEOUL    KS 152719      510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: GYRUS AMCI PK BUTTON ELECTRODE
GYRUS ACMI, INC.                  510(k) NO: K120567(TRADITIONAL)
ATTN: NEIL  KELLY                 PHONE NO : 508 804 2600   
136 TURNPIKE RD.                  SE DECISION MADE: 20-JUN-12
SOUTHBOROUGH MA 01772             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROMANIPULATOR SET
NARISHIGE CO., LTD.               510(k) NO: K120877(TRADITIONAL)
ATTN: MITSUKO  YONEYAMA           PHONE NO : 813 330 88383
27-9 MINAMIKARASUYAMA 4-CHOME     SE DECISION MADE: 20-JUN-12
SETAGAY-KU, TOKYO    JA 157-0062  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASCEND SHOULDER SYSTEM
TORNIER, INC.                     510(k) NO: K121493(SPECIAL)
ATTN: BRAHIM  HADRI               PHONE NO : 781 249 8030   
7701 FRANCE AVE SOUTH SUITE 600   SE DECISION MADE: 20-JUN-12
EDINA MN 55435   55435            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3
RANDOX LABORATORIES, LTD.         510(k) NO: K121588(TRADITIONAL)
ATTN: PAULINE  ARMSTRONG          PHONE NO : 440 289 4422413
55 DIAMOND RD.                    SE DECISION MADE: 20-JUN-12
CRUMLIN, COUNTY ANTRIM    UK BT29 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
PLAYTEX, INC.                     510(k) NO: K120245(TRADITIONAL)
ATTN: PUSHPA  RAO                 PHONE NO : 201 785 8070   
75 COMMERCE DRIVE                 SE DECISION MADE: 21-JUN-12
ALLENDALE NJ 07401                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS
ARROW INTERNATIONAL, INC.         510(k) NO: K113277(TRADITIONAL)
ATTN: TRACY  MADDOCK              PHONE NO : 610 378 0131   
2400 BERNVILLE RD.                SE DECISION MADE: 21-JUN-12
READING PA 19605                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER
QUALITY LIFE TECHNOLOGIES CO;LTD  510(k) NO: K112824(TRADITIONAL)
ATTN: LEON  LU                    PHONE NO : 877 202 1588   
3500 S.DUPONT HIGHWAY             SE DECISION MADE: 21-JUN-12
DOVER DE 19901                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM
LIFE TECHNOLOGIES, INC.           510(k) NO: K113566(TRADITIONAL)
ATTN: KELLI L TANZELLA            PHONE NO : 716 774 3122   
3175 STALEY RD.                   SE DECISION MADE: 21-JUN-12
GRAND ISLAND NY 14072             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASYDEX
VINELAND SYRUP INC.               510(k) NO: K120247(TRADITIONAL)
ATTN: ERIC  FEERST                PHONE NO : 609 970 9938   
57 HARTFORD ROAD                  SE DECISION MADE: 21-JUN-12
SEWELL NJ 08080                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROCOLL
INNONOLL PHARMACEUTICALS LTD.     510(k) NO: K120339(TRADITIONAL)
ATTN: AARON  WYSE                 PHONE NO : 353 087 0520845
MIDLANDS RESEARCH AND INNOVATION CSE DECISION MADE: 21-JUN-12
ATHLONE    EI EI                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WAVELIGHT FS200 PATIENT INTERFACE 1505
ALCON RESEARCH, LTD.              510(k) NO: K121031(ABBREVIATED)
ATTN: MICHAEL  BUENGER            PHONE NO : 817 551 8975   
6201 SOUTH FREEWAY                SE DECISION MADE: 21-JUN-12
FORT WORTH TX 76134 2099          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRTRAQ SP AIRTRAQ AVANT
PRODOL MEDITEC LTD.               510(k) NO: K121378(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 21-JUN-12
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AXERA ACCESS SYSTEM
ARSTASIS, INC.                    510(k) NO: K121521(SPECIAL)
ATTN: DEBRA  COGAN                PHONE NO : 650 261 8073   
740 Bay Rd                        SE DECISION MADE: 21-JUN-12
Redwood City CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM
MUI SCIENTIFIC                    510(k) NO: K120524(TRADITIONAL)
ATTN: TAMMY  MUI                  PHONE NO : 905 890 5525
145 TRADERS BLVD. EAST UNIT 33-34 SE DECISION MADE: 21-JUN-12
MISSISSAUGA    CA L4Z 3L3         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERSAVIT
SYNERGETICS, INC                  510(k) NO: K121675(TRADITIONAL)
ATTN: DAN  REGAN                  PHONE NO : 636 794 5013   
3845 CORPORATE CENTRE DRIVE       SE DECISION MADE: 21-JUN-12
O'FALLON MO 63368                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ZOLL PROPAQ XM
ZOLL MEDICAL CORPORATION          510(k) NO: K121367(TRADITIONAL)
ATTN: CHARLES W KOLIFRATH         PHONE NO : 978 421 9786   
269 MILL ROAD                     SE DECISION MADE: 21-JUN-12
CHELMSFORD MA 01824               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))
ETVIEW LTD.                       510(k) NO: K121028(TRADITIONAL)
ATTN: YORAM  LEVY                 PHONE NO : 972 463 88837
31 HAAVODA ST.                    SE DECISION MADE: 21-JUN-12
BINYAMINA    IS 30500             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP
HOSPIRA, INC.                     510(k) NO: K121032(SPECIAL)
ATTN: YULIYA  MATLIN              PHONE NO : 224 212 4857   
275 NORTH FIELD DR.               SE DECISION MADE: 21-JUN-12
LAKE FOREST IL 60045              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEAM BRUSH/BEAM APP
BEAM TECHNOLOGIES, LLC            510(k) NO: K121165(TRADITIONAL)
ATTN: ALEX  CURRY                 PHONE NO : 859 462 7562   
P.O. BOX 17541                    SE DECISION MADE: 21-JUN-12
LOUISVILLE KY 40217               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELIA  B2-GLYCOPROTEIN I IGA IMMUNOASSAY
PHADIA US INC.                    510(k) NO: K112414(TRADITIONAL)
ATTN: MARTIN  ROBERT MANN         PHONE NO : 269 492 1957   
4169 COMMERCIAL AVE.              SE DECISION MADE: 22-JUN-12
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PENTAX EPK-I5020 VIDEO PROCESSOR
PENTAX OF AMERICA, INC.           510(k) NO: K113873(TRADITIONAL)
ATTN: ROBERT  SCHIFF              PHONE NO : 973 227 1830   
1129 BLOOMFIELD AVENUE            SE DECISION MADE: 22-JUN-12
WEST CALDWELL NJ 07006            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHEATHES ULTRASOND GEL
SHEATHING TECHNOLOGIES, INC.      510(k) NO: K112827(TRADITIONAL)
ATTN: JENNIFER  DOWNING           PHONE NO : 408 782 2720   
18431 TECHNOLOGY DR.              SE DECISION MADE: 22-JUN-12
MORGAN HILL CA 95037              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUANTRA
HOLOGIC, INC.                     510(k) NO: K120472(TRADITIONAL)
ATTN: CATHERINE A WILLIAMS        PHONE NO : 408 352 0201   
2585 AUGUSTINE DR                 SE DECISION MADE: 22-JUN-12
SANTA CLARA CA 95054              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KIMGUARD ONE-STEP STERILIZATION WRAP
KIMBERLY-CLARK CORP.              510(k) NO: K112805(TRADITIONAL)
ATTN: BRENDA  SHELKEY             PHONE NO : 678 654 8021   
1400 HOLCOMB BRIDGE RD. BUILDING 3SE DECISION MADE: 22-JUN-12
ROSWELL GA 30076                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARBONAID C02 DIFFUSER
CARDIA INNOVATION AB              510(k) NO: K112975(TRADITIONAL)
ATTN: JEFFREY R SHIDEMAN          PHONE NO : 952 835 4018   
7307 GLOCHESTER DRIVE             SE DECISION MADE: 22-JUN-12
EDINA MN 55435                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRYO-TOUCH III
MYOSCIENCE INC                    510(k) NO: K120415(TRADITIONAL)
ATTN: TRACEY  HENRY               PHONE NO : 650 474 2600   
525 CHESAPEAKE DRIVE              SE DECISION MADE: 22-JUN-12
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMG RECORDING ELECTRODE ASSEMBLY
RHYTHMLINK INTERNATIONAL, LLC     510(k) NO: K120342(TRADITIONAL)
ATTN: JAMES  MEWBORNE             PHONE NO : 803 252 1222   
1140 FIRST ST. SOUTH              SE DECISION MADE: 22-JUN-12
Columbia SC 29209                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HERO GRAFT
HEMOSPHERE INC                    510(k) NO: K121532(SPECIAL)
ATTN: LAURIE  LYNCH               PHONE NO : 952 582 6909   
6545 CITY WEST PARKWAY            SE DECISION MADE: 22-JUN-12
EDEN PRAIRIE MN 55344             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN
SMITH & NEPHEW, INC.              510(k) NO: K121018(TRADITIONAL)
ATTN: JOHN  CONNOR                PHONE NO : 901 399 5944   
7135 GOODLETT FARMS PARKWAY       SE DECISION MADE: 22-JUN-12
CORDOVA TN 38016                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSULIN PEN NEEDLE
TIGER MEDICAL PRODUCTS LTD        510(k) NO: K120690(TRADITIONAL)
ATTN: DAVID  WANG                 PHONE NO : 862 163 866300
1 HUAIHAI ZHONG ROAD LIU LIN TOWERSE DECISION MADE: 22-JUN-12
SHANGHAI    CH 200021             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CS 8100 CS 8100 ACCESS
TROPHY                            510(k) NO: K120975(TRADITIONAL)
ATTN: MARIE-PIERRE  LABAT-CAMY    PHONE NO : 331 648 08500
4 RUE F. PELLOUTIER CROISSY BEAUBOSE DECISION MADE: 22-JUN-12
MARNE LA VALLEE CEDEX 2    FR 7743510(k) STATEMENT

DEVICE: TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER
ABBOTT VASCULAR                   510(k) NO: K121222(SPECIAL)
ATTN: SUZANNE  REDMAN             PHONE NO : 951 914 3243   
26531 YNEZ ROAD P.O. BOX 9018     SE DECISION MADE: 22-JUN-12
TEMECULA CA 92591                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K121646(SPECIAL)
ATTN: SHELLY  PEARCE              PHONE NO : 650 694 5988   
685 EAST MIDDLEFIELD ROAD         SE DECISION MADE: 22-JUN-12
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: XIA 4.5 SPINAL SYSTEM
STRYKER CORP                      510(k) NO: K121342(TRADITIONAL)
ATTN: TIFFANI  ROGERS             PHONE NO : 201 760 8206   
2 PEARL COURT                     SE DECISION MADE: 22-JUN-12
ALLENDALE NJ 07401                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K121577(SPECIAL)
ATTN: CHARLEMAGNE  CHUA           PHONE NO : 714 669 7896   
2441 MICHELLE DR                  SE DECISION MADE: 22-JUN-12
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT
BIO-RAD LABORATORIES              510(k) NO: K120959(TRADITIONAL)
ATTN: JUANG  WANG                 PHONE NO : 510 741 4609   
BIOPLEX 2200 DIVISION 5500 EAST SESE DECISION MADE: 22-JUN-12
BENICIA CA 94510                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EUROTROL GAS-ISE METABOLITES
EUROTROL B.V.                     510(k) NO: K121468(TRADITIONAL)
ATTN: PAUL B.P.  KOOIJMANS        PHONE NO : 313 186957 77
KEPLERLAAN 20                     SE DECISION MADE: 22-JUN-12
EDE    NL 6716 BS                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K121699(SPECIAL)
ATTN: SHELLY  PEARCE              PHONE NO : 650 694 5988   
685 East Middlefield Road         SE DECISION MADE: 22-JUN-12
Mountain View CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SYNGO.MR NEUROLOGY
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K121459(TRADITIONAL)
ATTN: MICHELLE L BYRNE            PHONE NO : 610 448 4293   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 22-JUN-12
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IPS E.MAX PRESS MULTI
IVOCLAR VIVADENT AG               510(k) NO: K120134(TRADITIONAL)
ATTN: DONNA M HARTNETT            PHONE NO : 716 691 2260   
175 PINEVIEW DR.                  SE DECISION MADE: 25-JUN-12
AMHERST NY 14228                  510(k) STATEMENT

DEVICE: NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U
HARTALEGA SDN BHD                 510(k) NO: K120336(TRADITIONAL)
ATTN: NURUL  AISYAH KONG          PHONE NO : 603 328 03888
NO. 7, KAWASAN PERUSAHAAN SURIA   SE DECISION MADE: 25-JUN-12
BESTARI JAYA    MY 45600          510(k) STATEMENT

DEVICE: AQUAMANTRYS3 BSC 9.1S
MEDTRONIC INC.                    510(k) NO: K121290(TRADITIONAL)
ATTN: TARA N TURNEY               PHONE NO : 603 294 5445   
180 INTERNATIONAL DRIVE           SE DECISION MADE: 25-JUN-12
PORTSMOUTH NH 03801               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE
BUSSE HOSPITAL DISPOSABLES, INC.  510(k) NO: K120002(TRADITIONAL)
ATTN: MUHAMAD  ANSARI             PHONE NO : 631 435 4711   
75 ARKAY DR.                      SE DECISION MADE: 26-JUN-12
HAUPPAUGE NY 11788                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XTRAFIX EXTERNAL FIXATION SYSTEM
EXTRAORTHO, INC.                  510(k) NO: K113383(TRADITIONAL)
ATTN: MARCOS  VELEZ-DURAN         PHONE NO : 703 562 9800   
901 KING STREET SUITE 200         SE DECISION MADE: 26-JUN-12
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYS*STIM 240
METTLER ELECTRONICS CORP.         510(k) NO: K113017(ABBREVIATED)
ATTN: CHRISTINA  CAYUELA          PHONE NO : 800 854 9305   
1333 SOUTH CLAUDINA ST.           SE DECISION MADE: 26-JUN-12
ANAHEIM CA 92805                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE HELENA V8 IMMUNODISPLACEMENT KIT
HELENA LABORATORIES UK LTD        510(k) NO: K111369(TRADITIONAL)
ATTN: PATRICIA  FRANKS            PHONE NO : 409 842 3715   
PO BOX 752, 1530 LINDEBERGH DRIVE SE DECISION MADE: 26-JUN-12
BEAUMONT TX 77704 0752            510(k) STATEMENT

DEVICE: SURGIMESH XB - SKIRTED
ASPIDE MEDICAL                    510(k) NO: K120025(SPECIAL)
ATTN: JOHN J SMITH                PHONE NO : 202 637 3638   
555 THIRTEENTH ST. NW COLUMBIA SQUSE DECISION MADE: 26-JUN-12
WASHINGTON DC 20004 1109          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLIDER PTCA BALLOON CATHETER
TRIREME MEDICAL, INC.             510(k) NO: K121681(SPECIAL)
ATTN: SHIVA  ARDAKANI             PHONE NO : 925 931 1300   
7060 Koll Center Parkway Suite 300SE DECISION MADE: 26-JUN-12
Pleasanton CA 94566               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM
STERIS CORPORATION                510(k) NO: K120632(TRADITIONAL)
ATTN: BILL  BRODBECK              PHONE NO : 440 392 7690   
5960 HEISLEY ROAD                 SE DECISION MADE: 26-JUN-12
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENSPIRE DISCECTOMY SYSTEM
SPINE VIEW, INC.                  510(k) NO: K120680(SPECIAL)
ATTN: DIANA  DEGREGORIO           PHONE NO : 510 623 1931   
48810 Kato Rd. Suite 100E         SE DECISION MADE: 26-JUN-12
Fremont CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DATACAPTOR SYSTEM
CAPSULE TECH INC.                 510(k) NO: K113835(TRADITIONAL)
ATTN: PETER  KELLEY               PHONE NO : 978 482 2300   
300 Brickstone Square Suite 203   SE DECISION MADE: 27-JUN-12
Andover MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DR GREENBURGS HYBRID ACRYLIC
ALWAYS MORE MARKETING INC         510(k) NO: K120371(ABBREVIATED)
ATTN: JONATHAN  GREENBURG         PHONE NO : 818 414 4817   
4535 W. SAHARA AVE., STE 200      SE DECISION MADE: 27-JUN-12
LAS VEGAS NV 89102                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DR GREENBURGS HYBRID VACUUM
ALWAYS MORE MARKETING INC         510(k) NO: K120372(ABBREVIATED)
ATTN: JONATHAN  GREENBURG         PHONE NO : 818 414 4817   
4535 W. SAHARA AVE., STE 200      SE DECISION MADE: 27-JUN-12
LAS VEGAS NV 89102                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GAM-200
GC AMERICA INC.                   510(k) NO: K120243(TRADITIONAL)
ATTN: MARK  HEISS                 PHONE NO : 708 926 3090   
3737 WEST 127TH STREET            SE DECISION MADE: 27-JUN-12
ALSIP IL 60803                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD
ORALABS, INC.                     510(k) NO: K113326(TRADITIONAL)
ATTN: TERESA  PURDUE              PHONE NO : 303 783 9499   
18685 EAST PLAZA DRIVE            SE DECISION MADE: 27-JUN-12
PARKER CO 80134                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXT GEN EMG ENDOTRACHEAL TUBE
MEDTRONIC XOMED, INC.             510(k) NO: K112686(TRADITIONAL)
ATTN: MAREK  PAWLOWSKI            PHONE NO : 904 279 7586   
6743 SOUTHPOINT DR. NORTH         SE DECISION MADE: 27-JUN-12
JACKSONVILLE FL 32216             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LDR SPINE SPINETUNE TL SPINAL SYSTEM
LDR SPINE USA INC.                510(k) NO: K120760(SPECIAL)
ATTN: KIERSTEN  SODERMAN          PHONE NO : 512 344 3370   
13785 RESEARCH BOULEVARD SUITE 200SE DECISION MADE: 27-JUN-12
AUSTIN TX 78750                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
GLOBE MEDICAL, INC.               510(k) NO: K121049(SPECIAL)
ATTN: MERIAM  YOUSSEF             PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 27-JUN-12
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANGE SPINAL SYSTEM (MESA AND DENALI)
K2M, INC.                         510(k) NO: K121016(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR., S.E., SUITE F1    SE DECISION MADE: 27-JUN-12
Leesburg VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)
POLYREMEDY, INC.                  510(k) NO: K121522(TRADITIONAL)
ATTN: GARY  MOCNIK                PHONE NO : 949 433 0413   
49 COASTAL OAK                    SE DECISION MADE: 27-JUN-12
ALISO VIEJO CA 92656              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIXEL APP
GAUSS SURGICAL, INC.              510(k) NO: K121274(SPECIAL)
ATTN: PEGGY  MCLAUGHLIN           PHONE NO : 650 520 7284   
22700 ALCALDE RD                  SE DECISION MADE: 27-JUN-12
CUPERTINO CA 95014                510(k) STATEMENT

DEVICE: VU APOD INTERVERTEBRAL BODY FUSION DEVICE
THEKEN SPINE, LLC                 510(k) NO: K121211(SPECIAL)
ATTN: DALE  DAVISON               PHONE NO : 330 239 7709   
1153 Medina Rd.                   SE DECISION MADE: 27-JUN-12
Medina OH 44256                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTISTETM SOLUTION WITH SYS VCIO
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K121295(TRADITIONAL)
ATTN: CHRISTINE  DUNBAR           PHONE NO : 925 602 8157   
4040 NELSON AVE.                  SE DECISION MADE: 27-JUN-12
CONCORD CA 94520                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARCHITECT HAVAB-G
ABBOT LABORATORIES                510(k) NO: K113704(TRADITIONAL)
ATTN: JUDITH  WALLACH             PHONE NO : 847 937 1132   
100 ABBOTT PARK RD. DEPT. 09VA, BLSE DECISION MADE: 28-JUN-12
ABBOTT PARK IL 60064 6092         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MED-RX PATIENT DELIVERY SET
BENLAN INC                        510(k) NO: K120375(TRADITIONAL)
ATTN: CHERYL  BROWN               PHONE NO : 905 829 5004
2760 BRIGHTON RD                  SE DECISION MADE: 28-JUN-12
OAKVILLE    CA L6H 5T4            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K103467(SPECIAL)
ATTN: SHIVEN  GANDHI              PHONE NO : 424 218 8322   
2151 E. GRAND AVE.                SE DECISION MADE: 28-JUN-12
EL SEGUNDO CA 90245               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN
PARAGON VISION SCIENCES           510(k) NO: K120996(TRADITIONAL)
ATTN: WILLIAM E MEYERS            PHONE NO : 480 507 7606   
947 EAST IMPALA AVE.              SE DECISION MADE: 28-JUN-12
MESA AZ 85204                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM
BAYER HEALTHCARE                  510(k) NO: K121087(SPECIAL)
ATTN: ROGER  SONNENBURG           PHONE NO : 574 256 3441   
430 SOUTH BEIGER ST.              SE DECISION MADE: 28-JUN-12
MISHAWAKA IN 46544                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONY PVM-2551MD OLED MONITOR
SONY ELECTRONICS, INC.            510(k) NO: K120611(TRADITIONAL)
ATTN: CYNTHIA  SINCLAIR           PHONE NO : 508 643 0434   
49 PLAIN STREET                   SE DECISION MADE: 28-JUN-12
NORTH ATTLEBORO MA 02760          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUVASIVE COROENT TITANIUM SYSTEM
NUVASIVE, INC.                    510(k) NO: K120918(TRADITIONAL)
ATTN: SHEILA  BRUSCHI             PHONE NO : 858 320 4515   
7475 LUSK BLVD                    SE DECISION MADE: 28-JUN-12
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WI-FI BODY SCALE
SHENZHEN HEALTHCARE ELECTRONIC TEC510(k) NO: K121527(TRADITIONAL)
ATTN: YANG  WANG                  PHONE NO : 867 552 7179235
NO. 3. JINPING ROAD YA'AN STREET, SE DECISION MADE: 28-JUN-12
TIANJIN    CH 300190              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIBEROPTIC LASER DELIVERY SYSTEM
FIBEROPTIC FABRICATIONS INC       510(k) NO: K120810(TRADITIONAL)
ATTN: CAROL J MORELLO             PHONE NO : 413 374 4303   
495 MAIN STREET                   SE DECISION MADE: 28-JUN-12
WILBRAHAM MA 01095                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOUNTED MEDICAL OXYGEN SYSTEM
ESSEX INDUSTRIES, INC.            510(k) NO: K113767(TRADITIONAL)
ATTN: KEN  SEISE                  PHONE NO : 314 832 8077   
8007 CHIVVIS DRIVE                SE DECISION MADE: 29-JUN-12
ST. LOUIS MO 63123                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM
OSTIAL CORPORATION                510(k) NO: K113775(SPECIAL)
ATTN: KAITLIN VON  HOFFMANN       PHONE NO : 650 903 9100   
510 CLYDE AVENUE                  SE DECISION MADE: 29-JUN-12
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE)
PALM BEACH DENTAL SUPPLY D/B/A TEK510(k) NO: K120218(TRADITIONAL)
ATTN: MICHAEL  CALHOUN            PHONE NO : 954 732 2514   
2700 NE 24TH ST                   SE DECISION MADE: 29-JUN-12
POMPANO BEACH FL 33069            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARCHSTENT BILIARY SYSTEM
OSTIAL CORPORATION                510(k) NO: K113582(TRADITIONAL)
ATTN: KAITLIN  VON HOFFMANN       PHONE NO : 650 903 9100   
510 CLYDE AVENUE                  SE DECISION MADE: 29-JUN-12
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARPATH 24
PROMEDIC, INC.                    510(k) NO: K112318(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 29-JUN-12
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AC WOUND TREATMENT SYSTEM
NANO VIBRONIX, INC.               510(k) NO: K111949(TRADITIONAL)
ATTN: E J SMITH                   PHONE NO : 410 451 0639   
1468 HARWELL AVE                  SE DECISION MADE: 29-JUN-12
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM
OSTIAL CORPORATION                510(k) NO: K121175(TRADITIONAL)
ATTN: KAITLIN VON  HOFFMANN       PHONE NO : 650 903 9100   
510 CLYDE AVENUE                  SE DECISION MADE: 29-JUN-12
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERTEX RCCONSTRUCTION SYSTEM
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K121191(TRADITIONAL)
ATTN: CLAIRE  EVANS               PHONE NO : 901 396 3133   
1800 PYRAMID PL.                  SE DECISION MADE: 29-JUN-12
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
SYNTHES INC                       510(k) NO: K121574(SPECIAL)
ATTN: ALAN T HALEY                PHONE NO : 484 356 9763   
1301 GOSHEN PARKWAY               SE DECISION MADE: 29-JUN-12
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   258                                     
                                                 TOTAL WITH SUMMARIES        239                                     
                                                 TOTAL WITH STATEMENTS        19