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
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