Medical Devices
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November 2011 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD November 2011 DEVICE: UC-CARE NAVIGO SYTEM UC-CARE LTD. 510(k) NO: K100784(TRADITIONAL) ATTN: JOHN KAHAN PHONE NO : 202 637 5794 555 THIRTEENTH STREET NW COLUMBIA SE DECISION MADE: 01-NOV-11 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOLTOUCH NEW STAR LASERS, INC. 510(k) NO: K103338(TRADITIONAL) ATTN: NATALIE R VOLLRATH PHONE NO : 916 677 1900 9085 FOOTHILLS BLVD. SE DECISION MADE: 01-NOV-11 ROSEVILLE CA 95747 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LCI OPTION FOR INNOCOR INNOVISION A/S 510(k) NO: K102047(TRADITIONAL) ATTN: H. CARL JENKINS PHONE NO : 847 234 7500 10 E. SCRANTON AVE., SUITE 201 SE DECISION MADE: 01-NOV-11 LAKE BLUFF IL 60044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EUS BALLOON UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K111028(TRADITIONAL) ATTN: CARROLL L MARTIN PHONE NO : 440 639 4494 5976 HEISELY RD. SE DECISION MADE: 01-NOV-11 MENTOR OH 44060 510(k) STATEMENT DEVICE: EYE-CEPT STERILE SALINE SOLUTION OPTICS LABORATORY, INC 510(k) NO: K110221(TRADITIONAL) ATTN: PATRICIA CHIU PHONE NO : 626 350 1926 9480 TELSTAR AVE SUITE 3 SE DECISION MADE: 01-NOV-11 EL MONTE CA 91731 2988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSTEK ZHONGSHAN TRANSTEK ELECTRONICS CO.510(k) NO: K112932(SPECIAL) ATTN: LEO WANG PHONE NO : 086 288 6083300 NO. 1 FANGHUA STREET HI-TECH DISTRSE DECISION MADE: 01-NOV-11 CHENGDU CH 610041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BODY ANALYSIS SCALE SHENZHEN HEALTHCARE ELECTRONIC TEC510(k) NO: K112951(SPECIAL) ATTN: CHARLIE MACK PHONE NO : 931 625 4938 77325 JOYCE WAY SE DECISION MADE: 01-NOV-11 ECHO OR 97826 510(k) STATEMENT DEVICE: BIOCERAMIC ORBITAL IMPLANT, ORBTEX CERAMISYS LTD. 510(k) NO: K110554(TRADITIONAL) ATTN: HILLARD W WELCH PHONE NO : 508 771 6777 344 ANNABELLE POINT ROAD SE DECISION MADE: 02-NOV-11 CENTERCILLE MA 02632 2402 510(k) STATEMENT DEVICE: MEDICAL MAGGOTS, LESOC MONARCH LABS, LLC. 510(k) NO: K102827(SPECIAL) ATTN: RONALD SHERMAN PHONE NO : 949 679 3000 17875 SKY PARK CIRCLE, SUITE K SE DECISION MADE: 02-NOV-11 IRVINE CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNA-EXTOR II BK MEDITECH CO., LTD. 510(k) NO: K110426(TRADITIONAL) ATTN: ELAINE DUNCAN PHONE NO : 715 549 6035 PO BOX 560 SE DECISION MADE: 02-NOV-11 STILLWATER MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) SPACELABS MEDICAL INC. 510(k) NO: K112962(SPECIAL) ATTN: DAVVID J GERAGHTY PHONE NO : 425 657 7200 5150 220TH AVE SE SE DECISION MADE: 02-NOV-11 ISSAQUAH WA 98029 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS KIMBERLY-CLARK CORPORATION 510(k) NO: K113036(SPECIAL) ATTN: LORI BARR PHONE NO : 920 721 4570 2001 MARATHON AVE SE DECISION MADE: 02-NOV-11 NEEAH WI 54956 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BINGO PRO FORUM ENGINEERING TECHNOLOGIES (96510(k) NO: K111474(TRADITIONAL) ATTN: YULIYA YUTKEVICH PHONE NO : 972 396 25517 1 PLATIN ST. NEW INDUSTRIAL ZONE SE DECISION MADE: 02-NOV-11 RISHON LEZION IS 75653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOURSNARE VASCULAR RETRIEVAL SNARE COOK, INC. 510(k) NO: K112185(TRADITIONAL) ATTN: MOLLY BUSENBARK PHONE NO : 812 339 2235 750 DANIELS WAY SE DECISION MADE: 02-NOV-11 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REFLEX BALLON GUIDE CATHETER REVERSE MEDICAL CORPORATION 510(k) NO: K112262(TRADITIONAL) ATTN: JEFFREY VALKO PHONE NO : 949 215 0660 13700 ALTON PARKWAY SUITE 167 SE DECISION MADE: 02-NOV-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NANO SUTURE ANCHOR LINVATEC CORPORATION D/B/A CONMED 510(k) NO: K112965(SPECIAL) ATTN: ASHLEA RICCI PHONE NO : 727 399 5564 11311 Concept Boulevard SE DECISION MADE: 02-NOV-11 LARGO FL 33773 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS THE SEE CLEAR COMPANY, INC 510(k) NO: K111345(TRADITIONAL) ATTN: KEVIN RANDALL PHONE NO : 303 828 0844 16576 W. 53RD WAY SE DECISION MADE: 02-NOV-11 GOLDEN CO 80403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM PHYGEN, LLC 510(k) NO: K112931(SPECIAL) ATTN: HARTMUT LOCH PHONE NO : 949 271 2417 2301 Dupont Drive, Suite 510 SE DECISION MADE: 02-NOV-11 Irvine CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI VECTRACOR, INC 510(k) NO: K102378(TRADITIONAL) ATTN: BRAD S SCHRECK PHONE NO : 973 768 0402 169 UNION BLVD SE DECISION MADE: 02-NOV-11 TOTOWA NJ 07512 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMO SCIENTIFIC MAS OMNI-CORE MICROGENICS CORPORATION 510(k) NO: K110738(TRADITIONAL) ATTN: LISA CHARTER PHONE NO : 510 979 5142 46360 FREMONT BLVD. SE DECISION MADE: 03-NOV-11 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE NEUROVISION MEDICAL PRODUCTS, INC.510(k) NO: K110989(TRADITIONAL) ATTN: CHRISTINE VERGELY PHONE NO : 805 866 6999 2225 SPERRY AVE, SUITE 1000 SE DECISION MADE: 03-NOV-11 VENTURA CA 93003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM LIGHTMED CORP. 510(k) NO: K103547(TRADITIONAL) ATTN: JOCELYN LIU PHONE NO : 886 226 881726 NO.1-1, LANE1,PAO-AN ST. SEC.3 SE DECISION MADE: 03-NOV-11 SHULIN CITY TW 238 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUTURA DR. OLIVER WENKER, M.D., M.B.A. 510(k) NO: K102524(TRADITIONAL) ATTN: COURTLAND IMEL PHONE NO : 972 241 8374 2300 VALLEY VIEW LANE, SUITE 230 SE DECISION MADE: 03-NOV-11 FARMERS BRANCH TX 75234 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HI TORQUE CONNECT GUIDEWIRE LAKE REGION MEDICAL 510(k) NO: K112381(TRADITIONAL) ATTN: KENNY WALSH PHONE NO : 353 913 85037 LAKE REGION MED INTL R&D CTR PARKMSE DECISION MADE: 03-NOV-11 GALWAY EI EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOVASCULAR LASER VEIN SYSTEM KIT BIOLITEC MEDICAL DEVICES, INC 510(k) NO: K112299(TRADITIONAL) ATTN: HARRY HAYES PHONE NO : 413 250 0779 1349 MAIN ROAD SE DECISION MADE: 03-NOV-11 GRANDVILLE MA 01034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM INRAD INC. 510(k) NO: K112945(SPECIAL) ATTN: RYAN GOOSEN PHONE NO : 616 301 7800 4375 DONKER CT SE SE DECISION MADE: 03-NOV-11 GRAND RAPIDS MI 49504 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR BRACCO DIAGNOSTIC, INC. 510(k) NO: K111648(SPECIAL) ATTN: TRACEY ALEXANDER PHONE NO : 609 524 2865 532 BROADHOLLOW ROAD SUITE 126 SE DECISION MADE: 03-NOV-11 MELVILLE NY 11747 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROBONE DENTAL GRAFTING MATERIAL CERAMISYS LTD 510(k) NO: K103820(TRADITIONAL) ATTN: HILLARD W WELCH PHONE NO : 508 771 6777 344 ANNABELLE POINT ROAD SE DECISION MADE: 03-NOV-11 CENTERVILLE MA 02632 2402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEQUALIS SHOULDER SYSTEM TORNIER 510(k) NO: K111902(TRADITIONAL) ATTN: SEVERINE BONNETON PHONE NO : 003 347 6613500 161 RUE LAVOISIER SE DECISION MADE: 03-NOV-11 MONTBONNOT, SAINT-ISMIER FR 383510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTO MITRA YELLOW LASER OPTO ELECTRONICA SA 510(k) NO: K111643(TRADITIONAL) ATTN: PAULO ANEAS LICHTI PHONE NO : 55 16 21067029 JOAQUIM A.R. DE SOUZA ST. 1071 - JSE DECISION MADE: 03-NOV-11 SAO CARLOS, SAO PAULO BR 13.563510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOHORIZONS ABUTMENTS FOR ZIMMER BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K103691(TRADITIONAL) ATTN: MICHAEL DAVIS PHONE NO : 205 967 7880 2300 RIVERCHASE CENTER SE DECISION MADE: 03-NOV-11 BIRMINGHAM AL 35244 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX 13400 IMPEDIMED LIMITED 510(k) NO: K100811(TRADITIONAL) ATTN: ALDEN KAY PHONE NO : 617 386 03700 5959 CORNERSTONE COURT WEST SUITE SE DECISION MADE: 04-NOV-11 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K103291(TRADITIONAL) ATTN: MICHAEL DAVIS PHONE NO : 205 967 7880 2300 RIVERCHASE CENTER SE DECISION MADE: 04-NOV-11 BIRMINGHAM AL 35244 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERDRY SILVER MILLIKEN HEALTHCARE PRODUCTS, LLC 510(k) NO: K110715(TRADITIONAL) ATTN: BRIAN J LINDSAY PHONE NO : 864 503 1323 920 MILLIKEN ROAD SE DECISION MADE: 04-NOV-11 SPARTANBURG SC 29303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERFSCAPE V2.0 OLEA MEDICAL 510(k) NO: K111161(TRADITIONAL) ATTN: KRISTI GUSMAN PHONE NO : 512 327 9997 611 WEST 5TH STREET THIRD FLOOR SE DECISION MADE: 04-NOV-11 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FXA (TM) ACES GMBH 510(k) NO: K110765(TRADITIONAL) ATTN: FRANK T TRAUTWEIN PHONE NO : 497 117 874162 LUDWIGSTR. 26 SE DECISION MADE: 04-NOV-11 FILDERSTADT, BW GM 70794 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDISIZE RED AND MEDISIZE BLUE QSERVE AMERICA, INC. 510(k) NO: K110246(SPECIAL) ATTN: WILLIAM GREENROSE PHONE NO : 603 369 3550 220 RIVER RD. SE DECISION MADE: 04-NOV-11 CLAREMONT NH 03743 5647 510(k) STATEMENT DEVICE: ASCENSION NUGRIP CMC IMPLANT ASCENSION ORTHOPEDIC 510(k) NO: K112278(TRADITIONAL) ATTN: BRADLEY W STRASSER PHONE NO : 512 836 5001 8700 CAMERON RD., STE. 100 SE DECISION MADE: 04-NOV-11 Austin TX 78754 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M VISUM ALERT ALARM MANAGEMENT SYSTEM MVISUM, INC. 510(k) NO: K112282(TRADITIONAL) ATTN: PRAVEEN DALA PHONE NO : 856 513 0732 200 FEDERAL STREET SUITE 230 SE DECISION MADE: 04-NOV-11 CAMDEN NJ 08103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM INFOPIA CO., LTD 510(k) NO: K103021(SPECIAL) ATTN: PRISCILLA CHUNG PHONE NO : 714 869 3080 951 STARBUCK ST. UNIT J SE DECISION MADE: 04-NOV-11 FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIMED CLAVICLE FIXATION SYSTEM TRIMED, INC. 510(k) NO: K112509(TRADITIONAL) ATTN: DOUG STEINBERGER PHONE NO : 661 255 7406 27533 AVENUE HOPKINS SE DECISION MADE: 04-NOV-11 SANTA CLARITA CA 91355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE) WOOJEON COMPANY 510(k) NO: K111392(TRADITIONAL) ATTN: PETER CHUNG PHONE NO : 412 687 3976 300 ATWOOD SE DECISION MADE: 04-NOV-11 PITTSBURGH PA 15213 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE PT. INTAN HEVEA INDUSTRY 510(k) NO: K111923(ABBREVIATED) ATTN: DARWIN TANDJO PHONE NO : 626 168 50169 JL. PULAU IRIAN (KAWASAN IND. MEDASE DECISION MADE: 04-NOV-11 SUDARSO KM. 10,5, MEDAN ID 2024510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLY-CHEM 90 ISE MODULE POLYMEDCO, INC. 510(k) NO: K112408(TRADITIONAL) ATTN: HELEN LANDICHO PHONE NO : 206 402 6146 510 FURNACE DOCK RD. SE DECISION MADE: 04-NOV-11 CORTLANDT MANOR NY 10567 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS BECKMAN COULTER, INC. 510(k) NO: K112603(ABBREVIATED) ATTN: CINDY MCGUIRE PHONE NO : 952 368 1142 1000 LAKE HAZELTINE DR. SE DECISION MADE: 04-NOV-11 CHASKA MN 55318 1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFTKAR PT SANO TRANSPORTGERAETE GMBH 510(k) NO: K111858(TRADITIONAL) ATTN: JEANINE A CARROCCIO PHONE NO : 630 891 2817 428 BELLEAIRE LANE SE DECISION MADE: 04-NOV-11 DOWNERS GROVE IL 60515 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLYGO PORTABLE OXYGEN CONCENTRATOR RESPIRONICS INC. 510(k) NO: K111885(SPECIAL) ATTN: JOSEPH E OLSAVSKY PHONE NO : 724 387 7562 1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 04-NOV-11 MONROEVILLE PA 15146 510(k) STATEMENT DEVICE: MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE... TGM MEDICAL, INC. 510(k) NO: K112285(TRADITIONAL) ATTN: DENNIS H CRANE PHONE NO : 952 374 6012 5145 Golden Foothill Parkway SuiteSE DECISION MADE: 04-NOV-11 El Dorado Hills CA 95762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K112142(TRADITIONAL) ATTN: ROSE T MARINELLI PHONE NO : 302 631 8805 P.O. BOX 6101 SE DECISION MADE: 04-NOV-11 NEWARK DE 19714 6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHO-JET CRYSTAL LANG DENTAL MFG. CO., INC. 510(k) NO: K112397(TRADITIONAL) ATTN: DAVID LANG PHONE NO : 847 215 6622 P.O BOX 969 SE DECISION MADE: 04-NOV-11 WHEELING IL 60090 0969 510(k) STATEMENT DEVICE: IT/IF CONTROL SEBIA 510(k) NO: K101863(TRADITIONAL) ATTN: KAREN ANDERSON PHONE NO : 770 446 3707 1705 CORPORATE DRIVE SUITE 400 SE DECISION MADE: 07-NOV-11 NORCROSS GA 30093 510(k) STATEMENT DEVICE: NUFACE PLUS CAROL COLE COMPANY 510(k) NO: K103472(ABBREVIATED) ATTN: BOB DUFFY PHONE NO : 858 487 1859 16405 SUMMER SAGE RD SE DECISION MADE: 07-NOV-11 POWAY CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S6 DIAGNOSTIC ULTRASOUND SYSTEM SONOSCAPE COMPANY LIMITED 510(k) NO: K112602(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 164 264467 P.O. BOX 237-023 SE DECISION MADE: 07-NOV-11 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAMINAR FLOW PHACO TIPS ABBOTT MEDICAL OPTICS INC 510(k) NO: K111882(ABBREVIATED) ATTN: ROSANNE M YETEMIAN PHONE NO : 714 247 8282 1700 EAST SAINT ANDREW PL SE DECISION MADE: 07-NOV-11 SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES ZERO-P VARIABLE ANGLE (VA) SYNTHES SPINE CO.LP 510(k) NO: K112068(TRADITIONAL) ATTN: STACEY BONNELL PHONE NO : 610 719 5895 1302 WRIGHTS LANE EAST SE DECISION MADE: 07-NOV-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR TOTOKU ELECTRIC CO., LTD 510(k) NO: K112145(TRADITIONAL) ATTN: TSUKASA TASHIRO PHONE NO : 81 258 246611 300 OYA SE DECISION MADE: 07-NOV-11 UEDA, NAGANO JA 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FM20 MEDIANA CO., LTD. 510(k) NO: K110612(TRADITIONAL) ATTN: AMY KIM PHONE NO : 823 374 25400 WONJU MEDICAL IND. PARK 1650-1 DONSE DECISION MADE: 08-NOV-11 WONJU-SI, GANGWON-DO KS 220-801510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT HORIBA ABX SAS 510(k) NO: K103788(TRADITIONAL) ATTN: CAROLINE FERRER PHONE NO : 33 467 141516 PARC EUROMEDECINE RUE DU CADUCEE -SE DECISION MADE: 08-NOV-11 MONTPELLIER FR 34184 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A) ABBCONCISE OPTICAL GROUP, LLC 510(k) NO: K111267(TRADITIONAL) ATTN: MARTIN DALSINGH PHONE NO : 970 243 5490 806 KIMBALL AVENUE SE DECISION MADE: 08-NOV-11 GRAND JUNCTION CO 81501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIR HEAT THERAPHY SYSYEMS SHENZHEN ANPAN TECHNOLOGY CO., LTD510(k) NO: K111273(TRADITIONAL) ATTN: WANG TAO PHONE NO : 867 558 9640313862 #44, 2ND ROAD, XIAKENG, TONGLE COMSE DECISION MADE: 08-NOV-11 SHENZHEN CH 518116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENTERAL FEEDING BAG AND SETS SHANDONG WEIGAO GROUP MEDICAL POLY510(k) NO: K102741(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 122 815850 P.O. BOX 237-023 SE DECISION MADE: 08-NOV-11 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROW FUSION NLT SPINE LTD 510(k) NO: K112359(TRADITIONAL) ATTN: JOHN J SMITH PHONE NO : 202 637 5600 555 THIRTEENTH STREET NW SE DECISION MADE: 08-NOV-11 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS 510(k) NO: K111615(TRADITIONAL) ATTN: CYNTHIA C KNAPP PHONE NO : 216 351 8735 982 KEYNOTE CIRCLE SE DECISION MADE: 08-NOV-11 CLEVELAND OH 44131 510(k) STATEMENT DEVICE: CALIX PC SPINAL IMPLANT SYSTEM X-SPINE SYSTEMS, INC 510(k) NO: K112036(TRADITIONAL) ATTN: DAVID KIRSCHMAN PHONE NO : 937 847 8400 452 Alexandersville Rd SE DECISION MADE: 08-NOV-11 Miamisburg OH 45342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSEAL G2 TISSUS SEALERS ETHICON ENDO-SUGERY, LLC 510(k) NO: K112033(TRADITIONAL) ATTN: DONOVAN MAY PHONE NO : 513 337 7981 4545 CREEK RD. SE DECISION MADE: 08-NOV-11 CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIBER DISK AND BLOCK BIOLOREN SRL 510(k) NO: K112186(TRADITIONAL) ATTN: ANDREA RATTI PHONE NO : 39 029 6703261 VIA ALESSANDRO VOLTA 59 SE DECISION MADE: 08-NOV-11 SARONNO IT -- 510(k) STATEMENT DEVICE: HI-TORQUE POWERTURN ABBOTT VASCULAR-CARDIAC THERAPIES 510(k) NO: K112957(TRADITIONAL) ATTN: KAY SETZER PHONE NO : 951 914 3242 26531 YNEZ RD. MAILING P.O. BOX 90SE DECISION MADE: 08-NOV-11 TEMECULA CA 92589 9018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) HEIDELBERG ENGINEERING GMBH 510(k) NO: K113129(TRADITIONAL) ATTN: GERGARD ZINSER PHONE NO : 496 221 64630 TIERGARTENSTRASSE 15 SE DECISION MADE: 08-NOV-11 HEIDELBERG GM 69121 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ACKERMANN EUROPCLIP ACKERMANN INSTRUMENTE GMBH 510(k) NO: K111930(TRADITIONAL) ATTN: KAREN E WARDEN, PHD PHONE NO : 440 729 8457 8202 SHERMAN ROAD SE DECISION MADE: 08-NOV-11 CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRANDIO CORE DUAL CURE VOCO GMBH 510(k) NO: K112447(TRADITIONAL) ATTN: T. GERKENSMEIER PHONE NO : 494 721 719200 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 08-NOV-11 CUXHAVEN GM D-27472 510(k) STATEMENT DEVICE: TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC SOMATEX MEDICAL TECHNOLOGIES GMBH 510(k) NO: K111692(SPECIAL) ATTN: HARALD JUNG PHONE NO : 497 461 969236 UNTERER WINKEL 3 SE DECISION MADE: 08-NOV-11 WURMLINGEN GM 78573 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM NANOVIS, LLC 510(k) NO: K110442(TRADITIONAL) ATTN: KEVIN A THOMAS, PHD PHONE NO : 858 792 1235 11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 09-NOV-11 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TELAMON PEEK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA 510(k) NO: K110562(TRADITIONAL) ATTN: REGINA HOLMES PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 09-NOV-11 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIRO PD PMD HEALTHCARE 510(k) NO: K103575(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410 451 0639 1468 HARWELL AVE. SE DECISION MADE: 09-NOV-11 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERPRESS UNIT HANURI DISTRIBUTION, INC 510(k) NO: K110276(TRADITIONAL) ATTN: JUNG HYUN MOON PHONE NO : 818 998 1023 9601 OWENSMOUTH AVENUE # 8 SE DECISION MADE: 09-NOV-11 CHATSWORTH CA 91311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUMELOCK CEMENTED SHOULDER PROSTHESIS FX SOLUTIONS 510(k) NO: K111097(TRADITIONAL) ATTN: CHERYL HASTINGS PHONE NO : 574 527 4220 1663 RUE DE MAJORNAS SE DECISION MADE: 09-NOV-11 VIRIAT FR 01440 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T:SLIM (TM) INSULIN DELIVERY SYSTEM TANDEM DIABETES CARE, INC. 510(k) NO: K111210(TRADITIONAL) ATTN: DON CANAL PHONE NO : 858 366 6963 11045 ROSELLE STREET SUITE 200 SE DECISION MADE: 09-NOV-11 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS STINGRAY SURGICAL PRODUCTS, INC 510(k) NO: K102752(TRADITIONAL) ATTN: MARK MCBRINN PHONE NO : 561 210 7582 801 APPLE TREE LANE SE DECISION MADE: 09-NOV-11 BOCA RATON FL 33486 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSITE VELOCITY SYSTEM V.3.0 ST. JUDE MEDICAL 510(k) NO: K112688(SPECIAL) ATTN: DONNA R LUNAK PHONE NO : 651 756 2944 ONE ST. JUDE MEDICAL DRIVE SE DECISION MADE: 09-NOV-11 ST. PAUL MN 55117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXERA ACCESS SYSTEM ARSTASIS, INC. 510(k) NO: K113110(SPECIAL) ATTN: DEBRA COGAN PHONE NO : 650 261 8073 740 Bay Rd SE DECISION MADE: 09-NOV-11 Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SWEETSPOT DIABETES DATA MANAGEMENT SERVICE SWEETSPOT DIABETES CARE, INC. 510(k) NO: K111509(TRADITIONAL) ATTN: CHRIS LOGAN PHONE NO : 503 893 2448 2538 NE 48TH AVE SE DECISION MADE: 09-NOV-11 PORTLAND OR 97213 1924 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER INTRICON DATRIX CORPORATION 510(k) NO: K112601(TRADITIONAL) ATTN: TANYA O'BRIEN PHONE NO : 813 645 2855 962 ALLEGRO LANE SE DECISION MADE: 09-NOV-11 APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CPK REAGENT VITAL DIAGNOSTICS (MANUFACTURING) 510(k) NO: K112416(TRADITIONAL) ATTN: MELITA LAMBIRIS PHONE NO : 610 387 936300 189-199 BROWNS ROAD SE DECISION MADE: 09-NOV-11 NOBLE PARK, VICTORIA AS 3174 510(k) STATEMENT DEVICE: ASIMANAGER - AT ARLINGTON SCIENTIFIC, INC. 510(k) NO: K111356(TRADITIONAL) ATTN: DAVID BINKS PHONE NO : 801 489 8911 1840 NORTH TECHNOLOGY DR. SE DECISION MADE: 09-NOV-11 SPRINGVILLE UT 84663 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASA 'MPHI FAMILY DIODE LASER CYNOSURE, INC. 510(k) NO: K111901(SPECIAL) ATTN: ANTHONY BURNS PHONE NO : 978 256 4200 5 CARLISLE ROAD SE DECISION MADE: 09-NOV-11 WESTFORD MA 01886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CATHETER CONNECTIONS' DUALCAP DUO CATHETER CONNECTIONS, INC. 510(k) NO: K112985(SPECIAL) ATTN: DONALD D SOLOMON PHONE NO : 801 209 1269 615 Arapeen Dr Ste 302A SE DECISION MADE: 09-NOV-11 Salt Lake City UT 84108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE NORTHSTAR HEALTHCARE HOLDINGS LIMI510(k) NO: K112988(TRADITIONAL) ATTN: ANTONIO L GIACCIO PHONE NO : 815 385 0100 1202 SOUTH ROUTE 31 SE DECISION MADE: 09-NOV-11 MCHENRY IL 60050 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FD TENS 2050 OR SLIDE TENS MODEL FD2050 FUJI DYNAMICS LTD 510(k) NO: K111645(TRADITIONAL) ATTN: CHING KONG (FELIX) LEE PHONE NO : 852 27 864218 UNIT 1-3, 23/F LAWS COMMERICAL PLASE DECISION MADE: 09-NOV-11 HONG KONG CH CH 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RUBICON SUPPORT CATHETER BOSTON SCIENTIFIC 510(k) NO: K112303(TRADITIONAL) ATTN: GLENN JACQUES PHONE NO : 763 494 1152 ONE SCIMED PLACE SE DECISION MADE: 09-NOV-11 MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT MONITOR MEDIANA CO., LTD. 510(k) NO: K112190(TRADITIONAL) ATTN: CHARLIE MACK PHONE NO : 931 625 4938 77325 JOYCE WAY SE DECISION MADE: 09-NOV-11 ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERCON HT DENTSPLY INTERNATIONAL, INC. 510(k) NO: K112152(TRADITIONAL) ATTN: HELEN LEWIS PHONE NO : 717 845 7511 SUSQUEHANNA COMMERCE CTR., 221 W. SE DECISION MADE: 09-NOV-11 YORK PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIFUNCTION KEITO AGUIFLAI IBERICA S.L. 510(k) NO: K103058(TRADITIONAL) ATTN: XAVIER CASALS PHONE NO : 349 375 40370 LA PUJADA 19 SE DECISION MADE: 10-NOV-11 VILASSAR DE MAR (BARCELONA) SP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BMR FACE BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K103031(TRADITIONAL) ATTN: ANNE-MARIE KEENAN PHONE NO : 353 917 74316 BMR HOUSE PARKMORE BUSINESS PARK, SE DECISION MADE: 10-NOV-11 GALWAY EI EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) NORAV MEDICAL LTD. 510(k) NO: K110463(SPECIAL) ATTN: BENRY ARAZY PHONE NO : 972 499 47880 INDUSTRIAL PARK 13 M.P. MISGAV SE DECISION MADE: 10-NOV-11 MITZPE AVIV IS 20187 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXGEN EXPANDABLE CATHETER NEXGEN MEDICAL SYSTEMS, INC. 510(k) NO: K102925(TRADITIONAL) ATTN: CRAIG PAGAN PHONE NO : 321 728 0126 1050 W. NASA BLVD. SUITE 136 SE DECISION MADE: 10-NOV-11 MELBOURNE FL 32901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-FORCE SEVEN SEAS DISTRIBTION AND MANUFAC510(k) NO: K111557(TRADITIONAL) ATTN: MARK IOELE PHONE NO : 213 613 2356 2620 S MARYLAND PKWY STE 14 UNIT 8SE DECISION MADE: 10-NOV-11 LAS VEGAS NV 89109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NH-301 AMBULATORY ECG ANALYSIS SOFTWARE NORAN MEDICAL CORP. 510(k) NO: K111487(SPECIAL) ATTN: BENNY ARAZY PHONE NO : 972 49 947880 INDUSTRIAL PARK 13, M.P. MISGAV SE DECISION MADE: 10-NOV-11 MITZPE AVIV IS 20187 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K113019(SPECIAL) ATTN: MATT PAUL PHONE NO : 901 367 4350 5677 AIRLINE RD. SE DECISION MADE: 10-NOV-11 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMEDITECH IMMUTEST MILTI-DRUG SCREEN AMEDITECH, INC. 510(k) NO: K113046(SPECIAL) ATTN: GREG CERRA PHONE NO : 858 805 8713 10340 CAMINO SANTA FE SUITE F SE DECISION MADE: 10-NOV-11 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS COMPRESSION THERAPY CONCEPTS, INC.510(k) NO: K112838(TRADITIONAL) ATTN: LEONARD NASS PHONE NO : 732 544 0800 35 JAMES WAY SE DECISION MADE: 10-NOV-11 EATONTOWN NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KNOTLESS SUTURE FIXATION SYSTEM CORE ESSENCE ORTHOPAEDICS 510(k) NO: K111716(TRADITIONAL) ATTN: JEFF MILLER PHONE NO : 215 310 9534 575A VIRIGINIA DR SE DECISION MADE: 10-NOV-11 FT. WASHINGTON PA 19034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHARTIS CONSOLE PULMONX, INC. 510(k) NO: K111764(SPECIAL) ATTN: HANS SCHULZ PHONE NO : 650 364 0400 700 CHESAPEAKE DRIVE SE DECISION MADE: 10-NOV-11 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XTRACT SYRINGE KEY SYSTEM XTRACT SOLUTIONS 510(k) NO: K112475(TRADITIONAL) ATTN: KEITH LOWREY PHONE NO : 503 206 4311 9495 SW LOCUST SUITE E SE DECISION MADE: 10-NOV-11 PORTLAND OR 97223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IGLUCOSE SYSTEM POSITIVEID CORPORATION 510(k) NO: K111932(TRADITIONAL) ATTN: EDWARD VALDEZ PHONE NO : 561 805 8000 1690 S. CONGRESS AVENUE Suite 200 SE DECISION MADE: 10-NOV-11 Delray Beach FL 33445 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CT-GUIDE NEEDLE GUIDANCE SYSTEM ACTIVIEWS LTD 510(k) NO: K113063(SPECIAL) ATTN: JOHN J SMITH PHONE NO : 202 637 3638 555 THIRTEENTH STREET, NW SE DECISION MADE: 10-NOV-11 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPI VARIO ANGLED ABUTMENT THOMMEN MEDICAL, AG 510(k) NO: K111984(TRADITIONAL) ATTN: LINDA K SCHULZ PHONE NO : 858 792 1235 11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 10-NOV-11 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VESSEL GUARDIAN LEXION MEDICAL, LLC. 510(k) NO: K112357(TRADITIONAL) ATTN: BERNARD HORWATH PHONE NO : 651 855 1447 545 ATWATER CIRCLE SE DECISION MADE: 10-NOV-11 ST PAUL MN 55103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR SAMSUNG MOBILE DISPLAY CO., LTD 510(k) NO: K112558(SPECIAL) ATTN: DAVE KIM PHONE NO : 713 467 2607 12946 KIMBERLEY LANE SE DECISION MADE: 10-NOV-11 HOUSTON TX 77079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL VILEX, INC. 510(k) NO: K102413(TRADITIONAL) ATTN: ABE LAVI PHONE NO : 941 373 3987 111 MOFFITT STREET SE DECISION MADE: 14-NOV-11 MCMINNVILLE TN 37110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR ACUMED LLC 510(k) NO: K112111(TRADITIONAL) ATTN: LINO TSAI PHONE NO : 503 627 9957 5885 NW CORNELIUS PASS RD. SE DECISION MADE: 14-NOV-11 HILLSBORO OR 97124 9432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES SMITH & NEPHEW, INC. 510(k) NO: K112406(TRADITIONAL) ATTN: DAVID HENLY PHONE NO : 901 399 6487 7135 GOODLET FARMS PARKWAY SE DECISION MADE: 14-NOV-11 CORDOVA TN 38016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIAN HIGH ENERGY LINEAR ACCELERATOR VARIAN MEDICAL SYSTEMS 510(k) NO: K112839(TRADITIONAL) ATTN: VY TRAN PHONE NO : 650 424 5731 3100 HANSEN WAY M/S E-110 SE DECISION MADE: 14-NOV-11 PALO ALTO CA 94304 1129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT KETTENBACH GMBH & CO KG 510(k) NO: K113279(SPECIAL) ATTN: SIMONE MATUSCHKA PHONE NO : 492 774 70539 IM HEERFELD 7 SE DECISION MADE: 14-NOV-11 ESCHENBURG GM 35713 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K111843(TRADITIONAL) ATTN: JANICE HASELTON PHONE NO : 978 749 1494 150 MINUTEMAN RD. SE DECISION MADE: 14-NOV-11 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMERGE FRACTIONAL LASER PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K111840(TRADITIONAL) ATTN: SHARON TIMBERLAKE PHONE NO : 781 993 2414 82 CAMBRIDGE ST. SE DECISION MADE: 14-NOV-11 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARGES IMAGING CONTRAST SPRAY ARGES IMAGING, INC 510(k) NO: K113263(TRADITIONAL) ATTN: REBECCA K PINE PHONE NO : 760 809 5178 129 NORTH HILL AVENUE SE DECISION MADE: 14-NOV-11 PASADENA CA 91106 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: REPROCESSED HAND ACTIVATE SEALER/DIVIDER ASCENT HEALTHCARE SOLUTIONS 510(k) NO: K111600(TRADITIONAL) ATTN: RAMONA KULIK PHONE NO : 480 763 2952 10232 SOUTH 51ST ST. SE DECISION MADE: 15-NOV-11 PHOENIX AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL MEDICA CORP. 510(k) NO: K111005(TRADITIONAL) ATTN: PHOTIOS MAKRIS PHONE NO : 781 175 4892 5 OAK PARK DRIVE SE DECISION MADE: 15-NOV-11 BEDFORD MA 01730 510(k) STATEMENT DEVICE: SONOSITE EDGE ULTRASOUND SYSTEM SONOSITE,INC. 510(k) NO: K113156(TRADITIONAL) ATTN: SCOTT PAULSON PHONE NO : 425 951 6926 21919 30TH DRIVE SE. SE DECISION MADE: 15-NOV-11 BOTHELL WA 98021 3904 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: RSP GLENOID BASEPLATE POROUS COATED ENCORE MEDICAL, L.P. 510(k) NO: K112069(TRADITIONAL) ATTN: WILLIAM GARZON PHONE NO : 512 834 6391 9800 METRIC BLVD. SE DECISION MADE: 15-NOV-11 AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERISPINEPS PEDICLE SCREW SAFE ORTHOPAEDICS 510(k) NO: K112453(ABBREVIATED) ATTN: PIERRE DUMOUCHEL PHONE NO : 330 321 056423 PARC DES BELLEVUES- ALLEE R LUXEMBSE DECISION MADE: 15-NOV-11 ERAGNY SUR OISE FR 95610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANATOMIC PEEK CERVICAL FUSION SYSTEM MEDTRONIC SOFAMOR DANCK USA, INC. 510(k) NO: K112444(TRADITIONAL) ATTN: BECKY RONNER PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 15-NOV-11 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEALTHTRACKER WISTRON CORPORATION 510(k) NO: K110770(TRADITIONAL) ATTN: TELING HSU PHONE NO : 886 266 258188 6TH FLOOR NO 127 WUGONG 2ND RD WUGSE DECISION MADE: 16-NOV-11 TAIPEI COUNTY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY VENTANA MEDICAL SYTEMS, INC 510(k) NO: K103818(TRADITIONAL) ATTN: GEORGE DE LA ROSA PHONE NO : 520 877 7061 1910 E. INNOVATIONS PARK DRIVE SE DECISION MADE: 16-NOV-11 TUCSON AZ 85755 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APOLLO POLLOGEN LTD 510(k) NO: K111026(TRADITIONAL) ATTN: YORAM LEVY PHONE NO : 972 463 88837 31 HAAVODA ST. SE DECISION MADE: 16-NOV-11 BINYAMINA IS 30500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS SYNTHES INC 510(k) NO: K111323(TRADITIONAL) ATTN: ALAN T HALEY PHONE NO : 484 356 9763 1301 GOSHEN PARKWAY SE DECISION MADE: 16-NOV-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIZION TREK DIAGNOSTIC SYSTEMS 510(k) NO: K112276(TRADITIONAL) ATTN: CYNTHIA C KNAPP PHONE NO : 216 351 8735 982 KEYNOTE CIRCLE SE DECISION MADE: 16-NOV-11 CLEVELAND OH 44131 510(k) STATEMENT DEVICE: STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM STRAUMANN USA 510(k) NO: K112280(SPECIAL) ATTN: ELAINE ALAN PHONE NO : 978 747 2513 60 MINUTEMAN ROAD SE DECISION MADE: 16-NOV-11 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SUQIAN RUIJANG MEDICAL SUPPLIES CO510(k) NO: K113195(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 1 JIAN XIANG YUAN NO. 209 BEI SI HSE DECISION MADE: 16-NOV-11 CHU XIAOAN CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SNORERX 9.0 CONSUMER HEALTH PRODUCTS, INC 510(k) NO: K112205(ABBREVIATED) ATTN: GARY MOCNIK PHONE NO : 949 433 0413 49 COASTAL OAK SE DECISION MADE: 16-NOV-11 ALISO VIEJO CA 92656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE RENU MEDICAL, INC. 510(k) NO: K111773(TRADITIONAL) ATTN: L BRUCE PIERSON PHONE NO : 425 353 1110 9800 EVERGREEN WAY SE DECISION MADE: 16-NOV-11 EVERETT WA 98204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOYALA SILKGEL FULL FACE MASK WEINMANN GERATE FUR MEDIZIN GMBH +510(k) NO: K112167(SPECIAL) ATTN: RALF EGENOLF PHONE NO : 49 40 54702370 KRONSAALSWEG 40 SE DECISION MADE: 16-NOV-11 HAMBURG GM 22525 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLINE PNEUMOPERITONEUM NEEDLE MEDLINE, INDUSTRIES, INC. 510(k) NO: K111955(TRADITIONAL) ATTN: MATT CLAUSEN PHONE NO : 847 643 4785 ONE MEDLINE PLACE SE DECISION MADE: 16-NOV-11 MUNDELEIN IL 60060 510(k) STATEMENT DEVICE: THE BELMONT BUDDY LITE FLUID WARMER BELMONT INSTRUMENT CORP. 510(k) NO: K112639(SPECIAL) ATTN: URAIWAN P LABADINI PHONE NO : 978 663 0212 780 BOSTON RD. SE DECISION MADE: 16-NOV-11 BILLERICA MA 01821 510(k) STATEMENT DEVICE: HYPERELASTIC WIRE ORMCO CORP. 510(k) NO: K112640(TRADITIONAL) ATTN: WENDY GARMAN PHONE NO : 714 516 7602 1717 WEST COLLINS AVENUE SE DECISION MADE: 16-NOV-11 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TASMAN RESMED LTD. 510(k) NO: K112393(TRADITIONAL) ATTN: DAVID D'CRUZ PHONE NO : 858 836 5984 9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 16-NOV-11 KEARNEY MESA CA 92123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTAL LASER THERAPY SYSTEM CHINA DAHENG GROUP, INC. 510(k) NO: K113212(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 122 815850 P.O. BOX 237-023 SE DECISION MADE: 16-NOV-11 SHANGHAI, CHINA CH 100085 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ACCELEDENT ORTHOACCEL TECHNOLOGIES, INC 510(k) NO: K110661(TRADITIONAL) ATTN: MICHAEL E KAUFMAN PHONE NO : 832 631 1657 8275 EL RIO, SUITE 100 SE DECISION MADE: 17-NOV-11 HOUSTON TX 77054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTELLIVUE MX40 PATIENT MONITOR PHILIPS MEDICAL SYSTEMS 510(k) NO: K113125(SPECIAL) ATTN: THERESA POOLE PHONE NO : 978 659 7621 3000 MINUTEMAN RD. SE DECISION MADE: 17-NOV-11 ANDOVER MA 01810 1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR SUQIAN RUIJANG MEDICAL SUPPLIES CO510(k) NO: K113191(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 1 JIAN XIANG YUAN NO. 209 BEI SI HSE DECISION MADE: 17-NOV-11 CHU XIAOAN CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES LCP PEDINTRIC PLATE SYSTEMS SYNTHES (USA) PRODUCTS LLC 510(k) NO: K112085(TRADITIONAL) ATTN: ANGELA F LASSUNDER PHONE NO : 601 719 6854 1301 GOSHEN PKWY. SE DECISION MADE: 17-NOV-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARWAY RX NB CATHETER ATRIUM MEDICAL CORP. 510(k) NO: K113112(SPECIAL) ATTN: MEGAN MCCAGH PHONE NO : 603 880 1433 5 WENTWORTH DR. SE DECISION MADE: 17-NOV-11 HUDSON NH 03051 510(k) STATEMENT DEVICE: HY-BOND RESIGLASS SHOFU DENTAL CORP. 510(k) NO: K111855(TRADITIONAL) ATTN: DAVID P MORAIS PHONE NO : 760 736 3277 1225 STONE DR. SE DECISION MADE: 17-NOV-11 SAN MARCOS CA 92078 510(k) STATEMENT DEVICE: MEMOMETAL INTRA-MEDULLARY BONE FASTENER MEMOMETAL TECHNOLOGIES 510(k) NO: K112197(SPECIAL) ATTN: GILLES AUDIC PHONE NO : 33 299 055969 CAMPUS DE KER LANN RUE BLAISE PASCSE DECISION MADE: 17-NOV-11 BRUZ FR F35170 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARFIL DC CORE PLUS KURARAY AMERICA, INC. 510(k) NO: K111982(TRADITIONAL) ATTN: KIYOYUKI ARIKAWA PHONE NO : 212 986 2230 600 LEXINGTON AVE. 26TH FLOOR SE DECISION MADE: 17-NOV-11 NEW YORK NY 10022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DREAMBOND BISCO, INC. 510(k) NO: K112118(TRADITIONAL) ATTN: MICHELLE SCHILTZ-TAING PHONE NO : 847 534 6146 1100 WEST IRVING PARK RD. SE DECISION MADE: 17-NOV-11 SCHAUMBURG IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOBCARDIO SYSTEM MOBHEALTH INCORPORATION 510(k) NO: K113234(TRADITIONAL) ATTN: PATRICIA LIN PHONE NO : 626 442 9886 5227 VILLAGE CIRCLE DR. SE DECISION MADE: 17-NOV-11 TEMPLE CITY CA 91780 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS ST. JUDE MEDICAL NEUROMODULATION 510(k) NO: K112214(TRADITIONAL) ATTN: PENNY HOUSTON PHONE NO : 972 526 4840 6901 PRESTON RD. SE DECISION MADE: 17-NOV-11 PLANO TX 75024 510(k) STATEMENT DEVICE: KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM MEDICATECH USA 510(k) NO: K112132(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO COURT SE DECISION MADE: 18-NOV-11 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER MEDTRONIC NEUROSURGERY 510(k) NO: K110560(TRADITIONAL) ATTN: JEFFREY HENDERSON PHONE NO : 805 571 8400 125 CREMONA DR. SE DECISION MADE: 18-NOV-11 GOLETA CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HIGH FLOW INSUFFLATION UNIT UHI-4 OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K110294(TRADITIONAL) ATTN: STACY ABBATIELLO KLUESNER PHONE NO : 484 896 5405 3500 CORPORATE PARKWAY SE DECISION MADE: 18-NOV-11 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMBU ASCOPE 2 AMBU A/S 510(k) NO: K110962(TRADITIONAL) ATTN: SANJAY PARIKH PHONE NO : 410 768 6464 6740 BAYMEADOW DR. SE DECISION MADE: 18-NOV-11 GLEN BURNIE MD 21060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MW100 (MAMMOGRAPHY) LCD MONITOR SYSTEM WIDE CORPORATION 510(k) NO: K110596(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 469 684 1980 1600 MANCHESTER WAY SE DECISION MADE: 18-NOV-11 CORINTH TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSEOTITE 2 DENTAL IMPLANTS BIOMET 3I, INC. 510(k) NO: K111216(SPECIAL) ATTN: MARTHA I GARAY PHONE NO : 561 776 6923 4555 RIVERSIDE DR. SE DECISION MADE: 18-NOV-11 PALM BEACH GARDENS FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIEZO BONE SURGERY GUILIN WOODPECKER MEDICAL INSTRUME510(k) NO: K111290(TRADITIONAL) ATTN: CHARLIE MACK PHONE NO : 931 625 4938 7325 JOYCE WAY SE DECISION MADE: 18-NOV-11 ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL SEPPIM S.A.S. 510(k) NO: K103376(TRADITIONAL) ATTN: DEBRA K HUTSON PHONE NO : 425 482 5174 21720 23RD DR SE SUITE 150 SE DECISION MADE: 18-NOV-11 BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS FOSHAN NANHAI BAI HE MEDICAL TECHN510(k) NO: K102833(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 164 264467 P.O. BOX 237-023 SE DECISION MADE: 18-NOV-11 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONCENTRA PROSTATE 4.0 NUCLETRON 510(k) NO: K112420(TRADITIONAL) ATTN: MICHAEL PAUL PHONE NO : 443 545 2182 7021 COLUMBIA GATEWAY DRIVE SUITE SE DECISION MADE: 18-NOV-11 COLUMBIA MD 21046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUARDIAN INFLATABLE BONE EXPANDER SYSTEM BM KOREA CO., LTD. 510(k) NO: K111593(TRADITIONAL) ATTN: RONALD D ARKIN PHONE NO : 770 565 6166 1733 CANTON LANE SE DECISION MADE: 18-NOV-11 MARIETTA GA 30062 2670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OBC BONE ANCHORED HEARING SYSTEM OTICON MEDICAL AB 510(k) NO: K112053(TRADITIONAL) ATTN: KAROLIN ISBERG JERNBY PHONE NO : 460 317 486153 EKONOMIVAGEN 2 SE DECISION MADE: 18-NOV-11 ASKIM SW SE-436 33 510(k) STATEMENT DEVICE: CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING CALYPSO MEDICAL TECHNOLOGIES INC 510(k) NO: K112768(TRADITIONAL) ATTN: MARCIA PAGE PHONE NO : 206 774 4234 2101 FOURTH AVE SUITE 500 SE DECISION MADE: 18-NOV-11 SEATTLE WA 98121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES USS CONNECTORS SYNTHES SPINE 510(k) NO: K111358(TRADITIONAL) ATTN: HEATHER GUERIN PHONE NO : 610 719 5432 1302 WRIGHTS LN EAST SE DECISION MADE: 18-NOV-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER BIOSENSE WEBSTER, INC. 510(k) NO: K112050(SPECIAL) ATTN: MARINA GUEVREKIAN PHONE NO : 909 839 8714 3333 DIAMOND CANYON RD SE DECISION MADE: 18-NOV-11 DIAMOND BAR CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS ELITECHGROUP 510(k) NO: K111960(TRADITIONAL) ATTN: DEBRA K HUTSON PHONE NO : 425 482 5174 21720 23RD DR SE SUITE 150 SE DECISION MADE: 18-NOV-11 BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONCO TRAC MODEL 1, 2, 4 TRANSLATIONAL SCIENCES CORPORATION510(k) NO: K111642(TRADITIONAL) ATTN: ALLEN GREEN, MD, PHD, JD PHONE NO : 617 447 5999 ONE MIFFLIN PLACE SUITE 400 SE DECISION MADE: 18-NOV-11 CAMBRIDGE MA 02138 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAROTID COIL SHANGHAI CHENGUANG MEDICAL TECHNOL510(k) NO: K112002(TRADITIONAL) ATTN: MEIJUAN CHEN PHONE NO : 862 152 961075833 BLDG 8, LANE 1199, JIDI ROAD SE DECISION MADE: 18-NOV-11 SHANGHAI CH 201107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX ZIMMER TRABECULAR METAL TECHNOLOGY510(k) NO: K111983(TRADITIONAL) ATTN: KATHLEEN RUTHERFORD PHONE NO : 973 576 0139 10 POMEROY RD. SE DECISION MADE: 18-NOV-11 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVO BARRIER TOPICAL EMULSION TRIGEN LABORATORIES, INC. 510(k) NO: K110762(TRADITIONAL) ATTN: GEORGE MCCAULEY PHONE NO : 803 831 7657 248 LATITUDE LANE SUITE 104 SE DECISION MADE: 18-NOV-11 LAKE WYLIE SC 29710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITREA CT MYOCARDIAL ANALYSIS VITAL IMAGES, INC. 510(k) NO: K112531(TRADITIONAL) ATTN: DANIEL BIANK PHONE NO : 952 487 9514 5850 OPUS PARKWAY, SUITE 300 SE DECISION MADE: 18-NOV-11 MINNETONKA MN 55343 4414 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOUNDATION DENTAL RESIN UNIX-JAPAN CO., LTD. 510(k) NO: K111709(TRADITIONAL) ATTN: TOSHIKO BOYD PHONE NO : 310 435 6358 10920 WILSHIRE BLVD SUITE 150 SE DECISION MADE: 18-NOV-11 LOS ANGELES CA 90024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAPAS CATHETER THERMOPEUTIX INC. 510(k) NO: K112219(TRADITIONAL) ATTN: THOMAS SCHROEDER PHONE NO : 858 549 1760 9925B BUSINESS PARK AVE. SE DECISION MADE: 18-NOV-11 SAN DIEGO CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSRADIAL ARTERY ACCESS DEVICES TELEFLEX MEDICAL, INC. 510(k) NO: K112554(TRADITIONAL) ATTN: CHRISTINE FORD PHONE NO : 610 378 0131 2400 BERNVILLE ROAD SE DECISION MADE: 18-NOV-11 READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO VIA MI WORKFLOWS SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K113029(SPECIAL) ATTN: ALAINE MEDIO PHONE NO : 865 218 2703 2501 NORTH BARRINGTON RD. SE DECISION MADE: 18-NOV-11 HOFFMAN ESTATES IL 60192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASS LP SPINAL SYSTEM MEDICREA INTERNATIONAL 510(k) NO: K112493(SPECIAL) ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD SE DECISION MADE: 21-NOV-11 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM SEJU ENGINEERING CO., LTD. 510(k) NO: K110614(TRADITIONAL) ATTN: EILEEN YANG PHONE NO : 824 247 62977 CERTIFICATION DIVISION D-524 MIGUNSE DECISION MADE: 21-NOV-11 YUSEONG-GU, DAEJEON KS 305-500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEM, INC. 510(k) NO: K112551(SPECIAL) ATTN: LISA M BOYLE PHONE NO : 610 984 9274 3773 CORPORATE PARKWAY SE DECISION MADE: 21-NOV-11 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIRODOC MEDICAL INTERNATIONAL RESEARCH USA510(k) NO: K103530(TRADITIONAL) ATTN: ED KOHERE PHONE NO : 262 656 6797 1900 PEWAUKEE ROAD SUITE O SE DECISION MADE: 21-NOV-11 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 EXACTECH, INC. 510(k) NO: K112097(TRADITIONAL) ATTN: VLADISLAVA ZAITSEVA PHONE NO : 352 377 1140 2320 N.W. 66TH CT. SE DECISION MADE: 21-NOV-11 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K113174(SPECIAL) ATTN: CHRIS MCKEE PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 21-NOV-11 Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLYDESDALES SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K112405(TRADITIONAL) ATTN: JULIE BASSETT PHONE NO : 901 399 3248 1800 PYRAMID PLACE SE DECISION MADE: 21-NOV-11 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE ALCON MANUFACTURING, LTD. 510(k) NO: K112425(TRADITIONAL) ATTN: MARTIN A KAUFMAN PHONE NO : 949 753 6250 15800 ALTON PKWY. SE DECISION MADE: 21-NOV-11 IRVINE CA 92618 3818 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHIBA SONO PAJUNK GMBH 510(k) NO: K113209(TRADITIONAL) ATTN: CHRISTIAN QUASS PHONE NO : 049 770 49291586 KARL-HALL-STRASSE 1 SE DECISION MADE: 21-NOV-11 GEISINGEN GM D-78187 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPONEER COLTENE/WHALEDENT AG 510(k) NO: K112168(TRADITIONAL) ATTN: MARK VAN METER PHONE NO : 330 916 8800 235 ASCOT PARKWAY SE DECISION MADE: 21-NOV-11 CUYAHOGA FALLS OH 44223 510(k) STATEMENT DEVICE: DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM MEDOS INTERNATIONAL SARL 510(k) NO: K112724(TRADITIONAL) ATTN: EUGENE BANG PHONE NO : 508 977 3966 325 PARAMOUNT DRIVE SE DECISION MADE: 21-NOV-11 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUCLEAR OPERATIVE HYSTEROSCOPE SMITH & NEPHEW, INC. 510(k) NO: K112134(TRADITIONAL) ATTN: JANICE HASELTON PHONE NO : 978 749 1494 150 MINUTEMAN RD. SE DECISION MADE: 22-NOV-11 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FEMTEC LASER SYSTEM FOR CAPSULOTOMY TECHNOLAS PERFECT VISION GMBH 510(k) NO: K110427(TRADITIONAL) ATTN: BETTY M JOHNSON PHONE NO : 714 273 8254 PO BOX 17190 SE DECISION MADE: 22-NOV-11 ANAHEIM CA 92817 7190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIGRA TAB, QUICKSPLINT MIGRAINE MIGRATHERAPY LLC 510(k) NO: K111066(TRADITIONAL) ATTN: BRADLEY ELI PHONE NO : 602 908 1680 4403 MANCHESTER AVENUE, SUITE 103 SE DECISION MADE: 22-NOV-11 ENCINITAS CA 92024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VTRUST FINGER TYPE PULSE OXIMETER TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K110893(TRADITIONAL) ATTN: TELING HSU PHONE NO : 886 266 258188 3F, 5F, NO 127 WUGONG 2ND RD WUGU SE DECISION MADE: 22-NOV-11 TAIPEI COUNTY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANYRIDGE INTERNAL IMPLANT SYSTEM MEGAGEN CO., LTD. 510(k) NO: K110955(TRADITIONAL) ATTN: APRIL LEE PHONE NO : 714 525 0114 325 N. PUENTE STREET UNIT B SE DECISION MADE: 22-NOV-11 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFIRE SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K103424(TRADITIONAL) ATTN: ALICIA BUSTOS-JUERGENSEN PHONE NO : 610 448 4056 51 VALLEY STREAM PARKWAY, E-50 SE DECISION MADE: 22-NOV-11 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K112963(TRADITIONAL) ATTN: TELING HSU PHONE NO : 886 266 258188 3F,5F, No.127, Wugong 2nd Rd. WuguSE DECISION MADE: 22-NOV-11 New Taipei City TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARVISION MIDMARK CORP. 510(k) NO: K112380(TRADITIONAL) ATTN: LISA BARTAKOVICS PHONE NO : 847 415 9800 675 HEATHROW DRIVE SE DECISION MADE: 22-NOV-11 LINCOLNSHIRE IL 60069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RENASYS AB ABOMINAL DRESSING KIT SMITH & NEPHEW, INC. 510(k) NO: K112784(SPECIAL) ATTN: LAURA D REYNOLDS PHONE NO : 727 329 7702 970 LAKE CARILLON DRIVE SUITE 110 SE DECISION MADE: 22-NOV-11 ST. PETERSBURG FL 33716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINIX-CCI TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K113052(SPECIAL) ATTN: PAUL BIGGINS PHONE NO : 714 669 7808 2441 MICHELLE DR. SE DECISION MADE: 22-NOV-11 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEVINE SPINAL SYSTEM CHANGZHOU ORTHMED MEDICAL INSTRUME510(k) NO: K111690(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 212 2815850 P.O. BOX 237-023 SE DECISION MADE: 22-NOV-11 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL DEVILBISS HEALTHCARE LLC 510(k) NO: K112220(TRADITIONAL) ATTN: JAMES P FROEHLICH PHONE NO : 814 443 7692 100 DEVILBISS HEALTHCARE SE DECISION MADE: 22-NOV-11 SOMERSET PA 15501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRAXION MEDICAL INTELLIGENCE MEDIZINTECHNI510(k) NO: K112210(TRADITIONAL) ATTN: MICHAEL WOLFF PHONE NO : 498 232 96920 ROBERT-BOSCH-STRASSE 8 SE DECISION MADE: 22-NOV-11 SCHWABMUNCHEN GM 86830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NB3D BONE VOID FILLER PIONEER SURGICAL TECHNOLOGY, INC. 510(k) NO: K111944(TRADITIONAL) ATTN: FLOYD G LARSON PHONE NO : 858 792 1235 11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 22-NOV-11 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM STERIS CORPORATION 510(k) NO: K112760(SPECIAL) ATTN: ROBERT SULLIVAN PHONE NO : 440 354 2600 5960 HEISLEY ROAD SE DECISION MADE: 22-NOV-11 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREMIER HB9210 HBA1C ANALYZER PRIMUS CORPORATION DBA TRINITY BIO510(k) NO: K112015(TRADITIONAL) ATTN: BRITT EINSPAHR PHONE NO : 716 483 7402 4231 E. 75TH TERRACE SE DECISION MADE: 22-NOV-11 KANSAS CITY MO 64132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO AORTIC VALVEGUIDE SOFTWARE SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K113027(SPECIAL) ATTN: PATRICIA D JONES PHONE NO : 610 484 3536 51 VALLEY STREAM PKWY. SE DECISION MADE: 22-NOV-11 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K113139(TRADITIONAL) ATTN: BERNICE LIN PHONE NO : 408 732 3856 670 Almanor Ave SE DECISION MADE: 22-NOV-11 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM WISTRON CORPORATION 510(k) NO: K112647(TRADITIONAL) ATTN: TELING HSU PHONE NO : 886 266 258188 3F, 5F, NO 127, WUGONG 2ND RD WUGUSE DECISION MADE: 22-NOV-11 NEW TAIPEI CITY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR ACCUMED HEALTHCARE (SHANGHAI) INC.510(k) NO: K112270(ABBREVIATED) ATTN: CYNTHIA (CINDY) GREEN PHONE NO : 425 432 8623 P.O. BOX 1277 SE DECISION MADE: 22-NOV-11 MAPLE VALLEY WA 98038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR ACCUMED HEALTHCARE (SHANGHAI) INC.510(k) NO: K112273(ABBREVIATED) ATTN: CYNTHIA (CINDY) GREEN PHONE NO : 425 765 9509 P.O. BOX 1277 SE DECISION MADE: 22-NOV-11 MAPLE VALLEY WA 98038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIMED BLOOD PRESSURE CUFF UNIMED MEDICAL SUPPLIES INC. 510(k) NO: K112544(TRADITIONAL) ATTN: XINMEI TAN PHONE NO : 867 552 6695165 NO.37, YANSHAN ROAD, SHEKOU SE DECISION MADE: 22-NOV-11 SHENZHEN, GUANGDONG CH 518067 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ZAVATION SPINAL SYSTEM ZAVATION LLC 510(k) NO: K112484(TRADITIONAL) ATTN: JOHN WALKER PHONE NO : 601 919 1119 501 AVALON WAY SE DECISION MADE: 22-NOV-11 BRANDON MS 39047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES WELCH ALLYN, INC. 510(k) NO: K112687(SPECIAL) ATTN: KEVIN CROSSEN PHONE NO : 315 685 2609 4341 STATE ST. RD. P.O. BOX 220 SE DECISION MADE: 22-NOV-11 SKANEATELES FALLS NY 13153 0220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION CLINICAL CHEMISTRY SYSTEM SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K112999(SPECIAL) ATTN: LORRAINE H PIESTRAK PHONE NO : 302 631 6279 P.O. BOX 6101 MIALSTOP 514 SE DECISION MADE: 22-NOV-11 NEWARK DE 19714 6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INGENUITY TF PET/MR PHILIPS HEALTHCARE (CLEVELAND) 510(k) NO: K103483(TRADITIONAL) ATTN: EDUARD TOEREK PHONE NO : 440 483 7672 595 MINER RD. SE DECISION MADE: 23-NOV-11 CLEVELAND OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITALOGRAPH MODEL 7100 - VITALOJAK VITALOGRAPH(IRELAND) LTD. 510(k) NO: K110525(TRADITIONAL) ATTN: TOM J HEALY PHONE NO : 353 656 864100 ENNIS INDUSTRIAL ESTATE GORT ROAD SE DECISION MADE: 23-NOV-11 ENNIS, CO. CLARE EI EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROM PLUS CLINICAL INNOVATIONS, LLC 510(k) NO: K110605(TRADITIONAL) ATTN: DEAN WALLACE PHONE NO : 801 268 2800 747 WEST 4170 SOUTH SE DECISION MADE: 23-NOV-11 MURRAY UT 84123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRABECULAR METAL (TM) FUSION DEVICE ZIMMER SPINE, INC 510(k) NO: K111119(TRADITIONAL) ATTN: JENNIFER TRIBBETT PHONE NO : 512 533 1061 12708 RIATA VISTA CIRCLE SUITE B-1SE DECISION MADE: 23-NOV-11 AUSTIN TX 78727 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS BIOKIT S.A. 510(k) NO: K110619(TRADITIONAL) ATTN: JOAN GUIXER PHONE NO : 349 386 09000 CAN MALE, S/N SE DECISION MADE: 23-NOV-11 LLISSA D'AMUNT, BARCELONA SP 08510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K102644(TRADITIONAL) ATTN: GERARD SADRAKULA PHONE NO : 914 524 2582 511 BENEDICT AVENUE SE DECISION MADE: 23-NOV-11 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNETOM AERA AND MAGNETOM SKYRA SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K111242(TRADITIONAL) ATTN: MICHELLE L BYRNE PHONE NO : 610 448 4293 51 VALLEY STREAM PKWY. SE DECISION MADE: 23-NOV-11 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HAMILTON-G5 HAMILTON MEDICAL AG 510(k) NO: K103803(TRADITIONAL) ATTN: FREDERIKE BRUEHSCHWEIN PHONE NO : 41 816 606010 VIA CRUSCH 8 SE DECISION MADE: 23-NOV-11 BONADUZ SZ CH-7402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SDX-4343CS SAMSUNG MOBILE DISPLAY CO., LTD 510(k) NO: K112751(SPECIAL) ATTN: DAVE KIM PHONE NO : 713 467 2607 12946 KIMBERLEY LANE SE DECISION MADE: 23-NOV-11 HOUSTON TX 77079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAROTID COIL GE 1.5T TURSIOP TECHNOLOGIES LLC 510(k) NO: K113280(TRADITIONAL) ATTN: RAJU VISWANTHAN PHONE NO : 216 658 4521 11000 CEDAR AVE., SUITE 280 SE DECISION MADE: 23-NOV-11 CLEVELAND OH 44106 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A JOY LONG 510(k) NO: K111748(TRADITIONAL) ATTN: JOY LONG PHONE NO : 317 496 8647 7750 ZIONSVILLE RD # 850 SE DECISION MADE: 23-NOV-11 INDIANAPOLIS IN 46268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFEMUR GLADIATOR HA HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K112150(TRADITIONAL) ATTN: MATT PAUL PHONE NO : 901 867 4350 5677 AIRLINE RD. SE DECISION MADE: 23-NOV-11 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOTDOG PATIENT WARMING SYSTEM AUGUSTINE BIOMEDICAL & DESIGN, LLC510(k) NO: K112488(TRADITIONAL) ATTN: WENDY NELSON PHONE NO : 952 465 3500 6581 CITY WEST PARKWAY SE DECISION MADE: 23-NOV-11 EDEN PRAIRIE MN 55344 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUIXIE NEBULIZER ODYSSEY MEDICAL TECHNOLOGIES 510(k) NO: K112564(TRADITIONAL) ATTN: DAVID PIPER PHONE NO : 916 483 3687 4807 EL CAMINO AVE, SUITE C SE DECISION MADE: 23-NOV-11 CARMICHAEL CA 95608 510(k) STATEMENT DEVICE: PENUMBRA SYSTEM MAX PENUMBRA, INC. 510(k) NO: K113163(SPECIAL) ATTN: SETH SCHULMAN PHONE NO : 510 748 3223 1351 Harbor Bay Parkway SE DECISION MADE: 23-NOV-11 Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHT GUIDE CABLE SCHOTT NORTH AMERICA 510(k) NO: K111342(TRADITIONAL) ATTN: JEFFREY ROBERTS PHONE NO : 508 643 0434 40 PLAIN STREET SE DECISION MADE: 25-NOV-11 NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYTOGUARD(TM) CLOSED LUER CONNECTOR B. BRAUN MEDICAL, INC. 510(k) NO: K112636(TRADITIONAL) ATTN: ANGELA J CARAVELLA PHONE NO : 610 596 2966 901 MARCON BLVD. SE DECISION MADE: 26-NOV-11 ALLENTOWN PA 18109 9341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPTOR FACET FIXATION SYSTEM ALPHATEC SPINE, INC. 510(k) NO: K110170(TRADITIONAL) ATTN: OLGA LEWIS PHONE NO : 760 494 6717 5818 EL CAMINO REAL SE DECISION MADE: 28-NOV-11 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K113153(SPECIAL) ATTN: SUSAN D GOLDSTEIN PHONE NO : 949 706 7456 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 28-NOV-11 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS SYNTHES (USA) PRODUCTS LLC 510(k) NO: K111891(SPECIAL) ATTN: CHRISTOPHER HACK PHONE NO : 610 719 6940 1303 GOSHEN PARKWAY SE DECISION MADE: 28-NOV-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML NAVILYST MEDICAL, INC. 510(k) NO: K113198(SPECIAL) ATTN: MARION W GORDON PHONE NO : 508 949 1129 26 FOREST STREET SE DECISION MADE: 28-NOV-11 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD EMERALD SINGLE USE, HYPODERMIC SYRINGE BECTON DICKINSON 510(k) NO: K113241(SPECIAL) ATTN: KARA MCKEE PHONE NO : 201 847 3247 1 BECTON DR. SE DECISION MADE: 28-NOV-11 FRANKLIN LAKES NJ 07417 1880 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURECORE BIOPSY DEVICE CHEST INNOVATIONS INC 510(k) NO: K102756(TRADITIONAL) ATTN: SALMAAN HAMEED PHONE NO : 408 826 9740 827 CANOAS CREEK CIRCLE SE DECISION MADE: 29-NOV-11 SAN JOSE CA 95136 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOUNDATION OLYMPUS TERUMO BIOMATERIALS CORPOR510(k) NO: K111087(TRADITIONAL) ATTN: PATSY J TRISLER PHONE NO : 301 652 5344 5600 WISONSIN AVENUE, #509 SE DECISION MADE: 29-NOV-11 CHEVY CHASE MD 20815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM RHAUSLER, INC. 510(k) NO: K111272(ABBREVIATED) ATTN: BARBARA DEBIASE PHONE NO : 303 537 3311 P.O. BOX 745039 SE DECISION MADE: 29-NOV-11 ARVADA CO 80006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM BIOMET MICROFIXATION, INC. 510(k) NO: K111908(TRADITIONAL) ATTN: KIM REED PHONE NO : 904 741 9443 1520 TRADEPORT DR. SE DECISION MADE: 29-NOV-11 JACKSONVILLE FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE BIOMERIEUX, INC. 510(k) NO: K110106(TRADITIONAL) ATTN: JOLYN TENLLADO PHONE NO : 314 731 8386 595 ANGLUM RD. SE DECISION MADE: 30-NOV-11 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL MEDCOMP (MEDICAL COMPONENTS) 510(k) NO: K110424(TRADITIONAL) ATTN: JEAN CALLOW PHONE NO : 215 256 4201 1499 DELP DRIVE SE DECISION MADE: 30-NOV-11 HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DESARA MINI CALDERA MEDICAL, INC. 510(k) NO: K103418(TRADITIONAL) ATTN: VICKI GAIL PHONE NO : 818 879 6555 5171 CLARETON DRIVE SE DECISION MADE: 30-NOV-11 AGOURA HILLS CA 91301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLAATZ 760 DRTECH CORP. 510(k) NO: K111655(SPECIAL) ATTN: CHOUL-WOO SHIN PHONE NO : 82 31 7306823 333-1, SANGDEAWON 1-DONG JUNGWON-GSE DECISION MADE: 30-NOV-11 SEONGNAM-SHI, GYEONGGI-DO KS 46510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-CONTACT TEAR FILM THERMOGRAGH UNITED INTEGRATED SERVICES CO., LT510(k) NO: K111771(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO.58, FU CHIUN STREET SE DECISION MADE: 30-NOV-11 HSIN CHU CITY TW 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CENTRICITY CARDIO IMAGING GE HEALTHCARE INTEGRATED IT SOLUTI510(k) NO: K112570(TRADITIONAL) ATTN: JOHN MANARIK PHONE NO : 847 277 5504 540 W. NW HIGHWAY SE DECISION MADE: 30-NOV-11 BARRINGTON IL 60010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 5MP MONOCHROME LCD MONITOR, RADIFORCE GX530 EIZO NANAO CORPORATION 510(k) NO: K112354(TRADITIONAL) ATTN: HIROAKI HASHIMOTO PHONE NO : 817 627 42468 153 SHIMOKASHIWANO, SE DECISION MADE: 30-NOV-11 HAKUSAN, ISHIKAWA JA 924-8566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHARGER PTA BALLON DILATATION CATHETER BOSTON SCIENTIFIC 510(k) NO: K112697(SPECIAL) ATTN: GLENN JACQUES PHONE NO : 763 494 1152 ONE SCIMED PLACE SE DECISION MADE: 30-NOV-11 MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALAMO C ALLIANCE PARTNERS, LLC 510(k) NO: K112361(TRADITIONAL) ATTN: JENNIFER PALINCHIK PHONE NO : 440 933 8850 33490 PIN OAK PARKWAY SE DECISION MADE: 30-NOV-11 AVON LAKE OH 44012 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 244 TOTAL WITH SUMMARIES 223 TOTAL WITH STATEMENTS 21
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