Medical Devices
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December 2011 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD December 2011 DEVICE: NEWPORT HT70 VENTILATOR NEWPORT MEDICAL INSTRUMENTS, INC. 510(k) NO: K111146(TRADITIONAL) ATTN: TOM COLONNA PHONE NO : 714 427 5811 1620 SUNFLOWER AVE. SE DECISION MADE: 01-DEC-11 COSTA MESA CA 92626 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE) YTY INDUSTRY (MANJUNG) SDN. BHD. 510(k) NO: K111248(TRADITIONAL) ATTN: JANNA TUCKER PHONE NO : 775 342 2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 01-DEC-11 SPARKS NV 89434 9550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT ASTRA TECH, INC. 510(k) NO: K112138(TRADITIONAL) ATTN: BETSY A BROWN PHONE NO : 847 560 4406 8944 TAMAROA TERR. SE DECISION MADE: 01-DEC-11 SKOKIE IL 60076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SNAP WOUND CARE SYSTEM SPIRACUR, INC. 510(k) NO: K113032(TRADITIONAL) ATTN: SARAH CANIO PHONE NO : 408 400 0856 755 N. MATHILDA AVENUE SE DECISION MADE: 01-DEC-11 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMSCO V-PRO STERIS CORP. 510(k) NO: K112813(SPECIAL) ATTN: ROBERT SULLIVAN PHONE NO : 440 354 2600 5960 HEISLEY RD. SE DECISION MADE: 01-DEC-11 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES MISONIX, INC. 510(k) NO: K112782(TRADITIONAL) ATTN: RONALD R MANNA PHONE NO : 631 694 9555 1938 NEW HIGHWAY SE DECISION MADE: 01-DEC-11 FARMINGDALE NY 11735 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JENSEN ZIRCONIA JENSEN INDUSTRIES, INC. 510(k) NO: K112806(ABBREVIATED) ATTN: GARY PHELPS PHONE NO : 203 239 2090 50 STILLMAN RD. SE DECISION MADE: 01-DEC-11 NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCULIF TL-PEEK IBF CAGE COALIGN INNOVATIONS, INC. 510(k) NO: K112095(TRADITIONAL) ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800 1331 H STREET NW 12TH FLOOR SE DECISION MADE: 01-DEC-11 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE ASAHI INTECC CO., LTD. 510(k) NO: K112979(TRADITIONAL) ATTN: YOSHI TERAI PHONE NO : 949 756 8252 2500 RED HILL AVE, SUITE 210 SE DECISION MADE: 01-DEC-11 SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LATERAL BUTTON T.A.G. MEDICAL PRODUCTS CORPORATIO510(k) NO: K112296(TRADITIONAL) ATTN: GEORGE J HATTUB PHONE NO : 508 479 6116 291 HILLSIDE AVE. SE DECISION MADE: 01-DEC-11 SOMERSET MA 02726 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS GRI MEDICAL & ELECTRONIC TECHNOLOG510(k) NO: K111458(TRADITIONAL) ATTN: PENNY NORTHCUTT PHONE NO : 678 428 6978 717 LAKEGLEN DRIVE SE DECISION MADE: 01-DEC-11 SUWANEE GA 30024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 TOSOH BIOSCIENCE, INC. 510(k) NO: K111335(TRADITIONAL) ATTN: JUDITH K OGDEN PHONE NO : 650 636 8112 6000 SHORELINE COURT SUITE 101 SE DECISION MADE: 01-DEC-11 SOUTH SAN FRANCISCO CA 94080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUIDELINER V2 CATHETER VASCULAR SOLUTIONS, INC. 510(k) NO: K112082(SPECIAL) ATTN: MATT NIENSTEDT PHONE NO : 763 656 4300 6464 SYCAMORE COURT SE DECISION MADE: 01-DEC-11 MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRESTIGE 24I; BIOLIS 24I; MGC 240 TOKYO BOEKI MEDISYS INC. 510(k) NO: K103531(TRADITIONAL) ATTN: JAMES M CLINTON PHONE NO : 919 247 0479 5105 FAIROAKS ROAD SE DECISION MADE: 01-DEC-11 DURHAM NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDROCOIL(R) EMBOLIC SYSTEM (HES) MICROVENTION, INC. 510(k) NO: K112181(SPECIAL) ATTN: VIN CUTARELLI PHONE NO : 714 247 8181 1311 VALENCIA AVE SE DECISION MADE: 01-DEC-11 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RENAISSANCE SYSTEM MAZOR ROBOTICS LTD 510(k) NO: K113228(SPECIAL) ATTN: AHAVA STEIN PHONE NO : 972 976 70002 20 HATA'AS ST. SE DECISION MADE: 01-DEC-11 KFAR SABA IS 44425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL RANDOX LABORATORIES, LTD. 510(k) NO: K112337(TRADITIONAL) ATTN: PAULINE ARMSTRONG PHONE NO : 440 289 4422413 55 DIAMOND RD. SE DECISION MADE: 01-DEC-11 CRUMLIN, COUNTY ANTRIM UK BT29 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NARAL CC RESMED SAS 510(k) NO: K113201(ABBREVIATED) ATTN: DAVID D'CRUZ PHONE NO : 858 836 5984 9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 01-DEC-11 SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENUINE FIRST AID CPR MASK GENUINE FIRST AID LLC 510(k) NO: K112126(TRADITIONAL) ATTN: GARY LEHNUS PHONE NO : 570 620 0198 150 CHERRY LANE RD. SE DECISION MADE: 01-DEC-11 EAST STROUDSBURG PA 18301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANCED TRAUMA DRESSING (ATD) NANOSYS, INC. 510(k) NO: K101257(TRADITIONAL) ATTN: HUGH DANIELS PHONE NO : 650 331 2108 2625 HANOVER STREET SE DECISION MADE: 01-DEC-11 PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE BEBE TOYS MANUFACTORY LTD. 510(k) NO: K110615(TRADITIONAL) ATTN: PAUL A WARE PHONE NO : 781 341 2488 34 MCNAMARA STREET SE DECISION MADE: 02-DEC-11 STOUGHTON MA 02072 510(k) STATEMENT DEVICE: ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 DNA GENOTEK INC 510(k) NO: K110701(TRADITIONAL) ATTN: CHANTAL HEMENS-DAVIS PHONE NO : 613 723 5757 2 BEAVERBROOK ROAD SE DECISION MADE: 02-DEC-11 OTTAWA ONTARIO CA K2K 1L1 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESENSOR WARFARIN SENSITIVITY SALIVA TEST GENMARK DIAGNOSTICS, INC 510(k) NO: K110786(TRADITIONAL) ATTN: JOHN RIOLO PHONE NO : 760 448 4300 5964 LA PLACE COURT SUITE 100 SE DECISION MADE: 02-DEC-11 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULISA SCI-70 ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. 510(k) NO: K113143(TRADITIONAL) ATTN: KEVIN J LAWSON PHONE NO : 716 691 0091 60 PINEVIEW DR. SE DECISION MADE: 02-DEC-11 BUFFALO NY 14228 2120 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM MEDAPPS, INC. 510(k) NO: K112559(SPECIAL) ATTN: KENT DICKS PHONE NO : 480 305 6323 7975 NORTH HAYDEN ROAD SUITE A-203SE DECISION MADE: 02-DEC-11 SCOTTSDALE AZ 85258 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM) OMNLIFE SCIENCE 510(k) NO: K112779(SPECIAL) ATTN: CHRISTINE NASSIF PHONE NO : 774 226 1871 50 O'CONNELL WAY SUITE 10 SE DECISION MADE: 02-DEC-11 EAST TAUNTON MA 02718 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOBILE MIM MIM SOFTWARE INC. 510(k) NO: K112930(TRADITIONAL) ATTN: LYNN HANIGAN PHONE NO : 216 455 0600 25200 Chagrin Blvd. SUITE 200 SE DECISION MADE: 02-DEC-11 Cleveland OH 44122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANTAGE TITAN HSR TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K112003(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714 730 5000 2441 MICHELLE DRIVE SE DECISION MADE: 02-DEC-11 TUSTIN CA 92781 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL COOPERVISION, INC. 510(k) NO: K113245(SPECIAL) ATTN: GWEN SHARP PHONE NO : 925 621 2457 6150 STONERIDGE MALL ROAD SUITE 37SE DECISION MADE: 02-DEC-11 PLEASANTON CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC COOPERVISION, INC. 510(k) NO: K113267(SPECIAL) ATTN: GWEN SHARP PHONE NO : 925 621 2457 6150 STONERIDGE MALL ROAD SUITE 37SE DECISION MADE: 02-DEC-11 PLEASANTON CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS ETHICON, INC. 510(k) NO: K111751(TRADITIONAL) ATTN: BRIAN A KANERVIKO PHONE NO : 908 218 3392 ROUTE 22 WEST SE DECISION MADE: 02-DEC-11 SOMERVILLE NJ 08876 0151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNESIUM ASSAY SEKISUI DIAGNOSTICS P.E.I. INC. 510(k) NO: K111915(TRADITIONAL) ATTN: PENNY J WHITE PHONE NO : 902 628 0934 70 WATTS AVENUE CHARLOTTETOWN SE DECISION MADE: 02-DEC-11 PRINCE EDWARD ISLAND CA C1E2B9 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNAMIC DU SERIES PORTABLE DENTAL UNIT SHANGHAI DYNAMIC INDUSTRY CO., LTD510(k) NO: K111907(TRADITIONAL) ATTN: DORIS DONG PHONE NO : 86 21 31261348 RM 1706, NO. 128 SONGLE RD SONGJIASE DECISION MADE: 02-DEC-11 SHANGHAI CH 201600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIOJET ULTRA DVX THROMBECTOMY SET MEDRAD, INC. 510(k) NO: K113428(SPECIAL) ATTN: MIKE BURNSIDE PHONE NO : 763 780 4555 9055 EVERGREEN BLVD N.W. SE DECISION MADE: 02-DEC-11 MINNEAPOLIS MN 55433 8003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOCARE MYHEALTH TABLET VOCARE, INC 510(k) NO: K111922(TRADITIONAL) ATTN: STEVE PEABODY PHONE NO : 317 973 1003 5225 EXPLORATION DRIVE SE DECISION MADE: 02-DEC-11 INDIANAPOLIS IN 46241 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS MEDTRONIC INC. 510(k) NO: K113235(SPECIAL) ATTN: AMRA RACIC PHONE NO : 763 514 9383 8200 CORAL SEA STREET NE SE DECISION MADE: 02-DEC-11 MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BENDINI(TM) SPINAL ROD BENDING SYSTEM NUVASIVE, INC. 510(k) NO: K111811(TRADITIONAL) ATTN: ELIAS KETCHUM PHONE NO : 858 320 4588 7475 LUSK BLVD SE DECISION MADE: 05-DEC-11 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EYE CARE CURE CONTACT LENS CASE EYE CARE AND CURE 510(k) NO: K112832(TRADITIONAL) ATTN: LINDY V DALEN PHONE NO : 520 321 1261 4646 S OVERLAND DR SE DECISION MADE: 05-DEC-11 TUCSON AZ 85714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS SYNTHES (USA) 510(k) NO: K111667(SPECIAL) ATTN: CHRISTOPHER HACK PHONE NO : 610 719 6940 1301 GOSHEN PKWY. SE DECISION MADE: 05-DEC-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 BIOSENSE WEBSTER, INC. 510(k) NO: K113213(SPECIAL) ATTN: JOHN JIMENEZ PHONE NO : 909 839 8534 3333 DIAMOND CANYON RD SE DECISION MADE: 05-DEC-11 DIAMOND BAR CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K112845(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949 706 7456 MDI CONSULTANTS, INC. 55 NORTHERN SE DECISION MADE: 05-DEC-11 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS) INPRO TECHNOLOGY DEVICE FACTORY 510(k) NO: K112610(TRADITIONAL) ATTN: MEIXIA WANG PHONE NO : 86 536 2197179 NO 10-1, XING'AN RD EAST LINQU SE DECISION MADE: 05-DEC-11 WEIFANG, SHANDONG CH 262600 510(k) STATEMENT DEVICE: AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER SALIENT SURGICAL TECHNOLOGIES, INC510(k) NO: K111732(TRADITIONAL) ATTN: MARTIN J LEIGHTON PHONE NO : 603 294 5446 180 INTERNATIONAL DRIVE SE DECISION MADE: 05-DEC-11 Portsmouth NH 03801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRIVO NM 615 GE HEALTHCARE 510(k) NO: K113350(SPECIAL) ATTN: ELI WERNER PHONE NO : 972 485 63666 4 HAYOZMA STREET SE DECISION MADE: 05-DEC-11 TIRAT HACARMEL IS 30200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES CORTICAL SCREWS SYNTHES (USA) PRODUCTS LLC 510(k) NO: K112583(TRADITIONAL) ATTN: REBECCA BLANK PHONE NO : 610 719 1268 1303 GOSHEN PARKWAY SE DECISION MADE: 05-DEC-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) AMEDITECH, INC. 510(k) NO: K113501(SPECIAL) ATTN: BRETT CASEY PHONE NO : 858 805 8713 10340 CAMINO SANTA FE SE DECISION MADE: 05-DEC-11 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXLE PEEK INTERSPINOUS FUSION SYSTEM X-SPINE SYSTEMS, INC 510(k) NO: K112592(SPECIAL) ATTN: DAVID KIRSCHMAN PHONE NO : 937 847 8400 452 Alexandersville Rd SE DECISION MADE: 05-DEC-11 Miamisburg OH 45342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT MERIDIAN BIOSCIENCE, INC. 510(k) NO: K112125(TRADITIONAL) ATTN: SUSAN D ROLIH PHONE NO : 513 271 3700 3471 RIVER HILLS DR. SE DECISION MADE: 05-DEC-11 CINCINNATI OH 45244 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCENSION ATLAS HUMERAL PLATING SYSTEM ASCENSION ORTHOPEDICS, INC. 510(k) NO: K110700(TRADITIONAL) ATTN: SUSAN WALTON PHONE NO : 512 836 5001 8700 CAMERON RD., STE. 100 SE DECISION MADE: 06-DEC-11 AUSTIN TX 78754 3832 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTAL 3D PLANNING SOFTWARE SYMBYO DENTAL, LLC 510(k) NO: K113404(TRADITIONAL) ATTN: PARUL CHANSORIA PHONE NO : 877 479 6296 87 HULME CT APT.216 SE DECISION MADE: 06-DEC-11 STANFORD CA 94305 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INFRARED EAR THERMOMETER RADIANT INNOVATION, INC. 510(k) NO: K111637(SPECIAL) ATTN: LYNN CHEN PHONE NO : 886 3 611666 1F,NO. 3,INDUSTRIAL E. 9TH RD SCIESE DECISION MADE: 06-DEC-11 HSINCHU TW 30075 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT ZIMMER DENTAL INC. 510(k) NO: K111889(TRADITIONAL) ATTN: MELISSA BURBAGE PHONE NO : 760 929 4300 1900 ASTON AVE. SE DECISION MADE: 06-DEC-11 CARLSBAD CA 92008 7308 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPARTAN S3 FACET SYSTEM AMENDIA, INC. 510(k) NO: K113011(SPECIAL) ATTN: RICH JANSEN PHONE NO : 612 281 5505 13540 GUILD AVENUE SE DECISION MADE: 06-DEC-11 APPLE VALLEY MN 55124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISCO SUBTALAR IMPLANT TRILLIANT SURGICAL LTD 510(k) NO: K111834(TRADITIONAL) ATTN: J D WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD SE DECISION MADE: 06-DEC-11 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL MEDICA CORP. 510(k) NO: K111363(TRADITIONAL) ATTN: PHOTIOS MAKRIS PHONE NO : 781 275 4892 5 OAK PARK DRIVE SE DECISION MADE: 06-DEC-11 BEDFORD MA 01730 510(k) STATEMENT DEVICE: NOVAPORT ONE VASCULAR ACCESS CANNULA NOVALUNG GMBH 510(k) NO: K112565(TRADITIONAL) ATTN: LEANN CHRISTMAN PHONE NO : 734 995 9089 3550 WEST LIBERTY RD. SE DECISION MADE: 06-DEC-11 ANN ARBOR MI 48103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: H-WAVE ELECTRONIC WAVEFORM LAB, INC. 510(k) NO: K112485(TRADITIONAL) ATTN: RYAN P HEANEY PHONE NO : 800 874 9283 5702 BOLSA AVE. SE DECISION MADE: 06-DEC-11 HUNTINGTON BEACH CA 92649 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER EDWARDS LIFESCIENCES, LLC. 510(k) NO: K113182(SPECIAL) ATTN: SPENCER WALKER PHONE NO : 801 565 6103 12050 LONE PEAK PKWY SE DECISION MADE: 07-DEC-11 DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS SYNERGETICS, INC 510(k) NO: K110924(TRADITIONAL) ATTN: GARY OLIVEROS PHONE NO : 636 794 5107 3845 CORPORATE CENTRE DRIVE SE DECISION MADE: 07-DEC-11 O'FALLON MO 63368 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DORNIER MEDILAS D LITEBEAM+ 1470 DORNIER MEDTECH AMERICA, INC. 510(k) NO: K110364(TRADITIONAL) ATTN: JOHN HOFFER PHONE NO : 770 514 6163 1155 ROBERTS BLVD. SE DECISION MADE: 07-DEC-11 KENNESAW GA 30144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE TERANG NUSA SDN BHD 510(k) NO: K110698(TRADITIONAL) ATTN: ROBERT HILL PHONE NO : 609 774 7171 1, JALAN 8, PENGKALAN CHEPA 2 IND.SE DECISION MADE: 07-DEC-11 KOTA BHARU, KELANTAN MY 16100 510(k) STATEMENT DEVICE: 3M TEGADERM MATRIX DRESSING 3M COMPANY 510(k) NO: K110457(TRADITIONAL) ATTN: MARIA RUIZ PHONE NO : 651 736 2733 3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 07-DEC-11 ST. PAUL MN 55133 3275 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM MODEL 8000-04944, IBGSTAR DIABETES MANAGER APPLICATION, REV D MODEL 8400-05948 AGAMATRIX INC 510(k) NO: K103544(TRADITIONAL) ATTN: WILLIAM H MCGRAIL PHONE NO : 603 328 6051 7C RAYMOND AVE SE DECISION MADE: 07-DEC-11 SALEM NH 03079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATHENA PEDICLE SCREW SYSTEM ROYAL OAK MEDICAL DEVICES 510(k) NO: K110046(TRADITIONAL) ATTN: MATHEW KROLL PHONE NO : 248 628 2830 39533 WOODWARD AVENUE SE DECISION MADE: 07-DEC-11 BLOOMFIELD HILLS MI 48304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K113179(TRADITIONAL) ATTN: ROBERT F LAWRENCE PHONE NO : 650 694 5984 1230 SHOREBIRD WAY SE DECISION MADE: 07-DEC-11 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: JOULE CLEARSENSE LASER SYSTEM SCITON, INC. 510(k) NO: K111483(TRADITIONAL) ATTN: JAY M PATEL PHONE NO : 650 493 9155 925 COMMERCIAL ST. SE DECISION MADE: 07-DEC-11 PALO ALTO CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SWIFT FX BELLA RESMED LTD. 510(k) NO: K112489(SPECIAL) ATTN: KIM K LEE PHONE NO : 612 888 41000 1 ELIZABETH MACARTHUR DR SE DECISION MADE: 07-DEC-11 BELLA VISTA NEWSOUTH WALES AS 2510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEITY 37% PHOSPHORIC ACID ETCHANT GEL MYCONE DENTAL SUPPLY CO., INC. 510(k) NO: K112597(TRADITIONAL) ATTN: WILLIAM EVANS PHONE NO : 856 663 4700 616 HOLLYWOOD AVE. SE DECISION MADE: 07-DEC-11 CHERRY HILL NJ 08002 510(k) STATEMENT DEVICE: DSJ MASSAGER MEGO AFEK AC LTD 510(k) NO: K112479(TRADITIONAL) ATTN: JAMES R RAVITZ, ESQ. PHONE NO : 202 857 8903 1050 CONNECTICUT AVENUE, NW. SE DECISION MADE: 07-DEC-11 WASHINGTON DC 20036 510(k) STATEMENT DEVICE: LARGE/EXTRA LAGRE CONDOM KAREX INDUSTRIES SDN BHD. 510(k) NO: K113061(SPECIAL) ATTN: LAI PENG PHONE NO : 607 687 8833 PTD. 7906 & 7907, TAMAN PONTIAN JASE DECISION MADE: 07-DEC-11 JOHOR DARUL TAKZIM MY 82000 510(k) STATEMENT DEVICE: AIR-N-GO SATELEC 510(k) NO: K110379(TRADITIONAL) ATTN: RICK ROSATI PHONE NO : 800 289 6367 124 GAITHER DRIVE SUITE 140 SE DECISION MADE: 08-DEC-11 MT. LAUREL NJ 08054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHIELD KYPHOPLASTY SYSTEM SOTEIRA, INC. 510(k) NO: K093477(TRADITIONAL) ATTN: PAMELA PAPINEAU PHONE NO : 978 772 3552 5 WHITCOMB AVENUE SE DECISION MADE: 08-DEC-11 AYER MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRESSON ELECTRODE PERSYST DEVELOPMENT CORP. 510(k) NO: K103103(TRADITIONAL) ATTN: SCOTT B WILSON PHONE NO : 858 755 4568 3177 CLEARWATER DRIVE SE DECISION MADE: 08-DEC-11 PRESCOTT AZ 86305 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRUX MOUTHGUARDS DENTAL ARTE, INC. 510(k) NO: K111310(TRADITIONAL) ATTN: CAROLYN PRIMUS PHONE NO : 941 753 9737 7046 OWL'S NEST TERR SE DECISION MADE: 08-DEC-11 BRADERDON FL 34203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARILIFT CERVICAL INTERBODY FUSION SYSTEM WENZEL SPINE 510(k) NO: K111123(TRADITIONAL) ATTN: SOURABH MISHRA PHONE NO : 512 501 4017 1001 OAKWOOD BLVD SE DECISION MADE: 08-DEC-11 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUA LUBE MAYER LABORATORIES, INC. 510(k) NO: K110325(TRADITIONAL) ATTN: DAVID P MAYER PHONE NO : 510 229 5300 1950 ADDISON STREET, SUITE 101 SE DECISION MADE: 08-DEC-11 BERKELY CA 94704 1182 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BONE PLATE; BONE SCREW BIOMATERIALS KOREA INC. 510(k) NO: K110926(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720 962 5412 5401 S. COTTONWOOD CT. SE DECISION MADE: 08-DEC-11 GREENWOOD VILLAGE CO 80121 510(k) STATEMENT DEVICE: MODEL PM3030 OMRON HEALTHCARE, INC. 510(k) NO: K110068(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 08-DEC-11 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K111646(TRADITIONAL) ATTN: DEBBIE PEACOCK PHONE NO : 203 602 3774 419 WEST AVE. SE DECISION MADE: 08-DEC-11 STAMFORD CT 06902 6300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZAVATION CERVICAL PLATE SYSTEM ZAVATION LLC 510(k) NO: K112533(TRADITIONAL) ATTN: JOHN WALKER PHONE NO : 601 919 1119 501 AVALON WAY SE DECISION MADE: 08-DEC-11 BRANDON MS 39047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXACTECH EQUINOXE CAGE GLENOIDS EXACTECH, INC. 510(k) NO: K113309(SPECIAL) ATTN: PATRICK HUGHES PHONE NO : 352 327 4762 2320 NW 66TH COURT SE DECISION MADE: 08-DEC-11 GAINESVILLE FL 32605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION INOVO, INC. 510(k) NO: K113111(SPECIAL) ATTN: MICHAEL T DILDINE PHONE NO : 239 643 6577 2975 S. HORSESHOE DRIVE SUITE 600 SE DECISION MADE: 08-DEC-11 NAPLES FL 34104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGLED TAPERED ABUTMENT ZIMMER DENTAL INC. 510(k) NO: K111853(TRADITIONAL) ATTN: MELISSA BURBAGE PHONE NO : 760 929 4300 1900 ASTON AVE. SE DECISION MADE: 08-DEC-11 CARLSBAD CA 92008 7308 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPLIT CATH III MEDICAL COMPONENTS INC 510(k) NO: K111651(TRADITIONAL) ATTN: JEAN CALLOW PHONE NO : 215 256 4201 1499 DELP DRIVE SE DECISION MADE: 08-DEC-11 HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES INTUITIVE SURGICAL, INC. 510(k) NO: K112208(TRADITIONAL) ATTN: BRANDON HANSEN PHONE NO : 408 523 2100 1266 KIFER RD SE DECISION MADE: 08-DEC-11 SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER KEELER INSTRUMENTS, INC. 510(k) NO: K112093(SPECIAL) ATTN: EUGENE R VANARSDALE PHONE NO : 610 353 4350 456 PKWY. SE DECISION MADE: 08-DEC-11 BROOMALL PA 19008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES TUTTNAUER CO. LTD. 510(k) NO: K111736(TRADITIONAL) ATTN: THEODORE SULLIVAN PHONE NO : 202 452 7992 1700 K STREET NW SUITE 300 SE DECISION MADE: 08-DEC-11 WASHINGTON DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED ROG SUTURE ANCHOR ROG SPORTS MEDICINE, INC. 510(k) NO: K112991(SPECIAL) ATTN: CURTIS RAYMOND PHONE NO : 203 922 0105 80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 08-DEC-11 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER BAXTER HEALTHCARE CORP. 510(k) NO: K113227(SPECIAL) ATTN: NANETTE HEDDEN PHONE NO : 847 270 4871 1 BAXTER PKWY. SE DECISION MADE: 08-DEC-11 DEERFIELD IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM GENESYS SPINE 510(k) NO: K111132(TRADITIONAL) ATTN: BRIAN J BERGERON PHONE NO : 512 381 7071 1250 CAPITAL OF TEXAS HWY SO. BUILSE DECISION MADE: 09-DEC-11 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE BUZZ FACIAL TONING SYSTEM DAKA INTERNATIONAL LTD. 510(k) NO: K102494(TRADITIONAL) ATTN: BOB WAGNER PHONE NO : 865 982 5552 1131 ANTHEM VIEW LANE SE DECISION MADE: 09-DEC-11 KNOXVILLE TN 37922 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RENOVIS CANNULATED SCREW SYSTEM RENOVIS SURGICAL TECHNOLOGIES, LLC510(k) NO: K113084(SPECIAL) ATTN: DAVID F ROTHKOPF PHONE NO : 508 231 8842 200 HOMER AVE. SE DECISION MADE: 09-DEC-11 ASHLAND MA 01721 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SARN CENTRIFUGAL PUMP TERUMO CARDIOVASCULAR SYSTEMS 510(k) NO: K112229(TRADITIONAL) ATTN: REBECCA ANDERSEN PHONE NO : 734 741 6113 6200 JACKSON RD SE DECISION MADE: 09-DEC-11 ANN ARBOR MI 48103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD 510(k) NO: K111826(SPECIAL) ATTN: LIU YI PHONE NO : 862 260 5261618060 NO 3, JIN PING ST, YA AN RD NANKASE DECISION MADE: 09-DEC-11 TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANADY VIEIRA HYBRID PLASMA SCALPEL US MEDICAL INNOVATIONS LLC 510(k) NO: K113500(TRADITIONAL) ATTN: JEROME CANADY PHONE NO : 863 667 1609 2940 WINTER LAKE ROAD SE DECISION MADE: 09-DEC-11 LAKELAND FL 33803 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ACTIV VARNISH PULPDENT CORPORATION 510(k) NO: K112946(TRADITIONAL) ATTN: KENNETH J BERK PHONE NO : 617 926 6666 80 OAKLAND ST. P.O. BOX 780 SE DECISION MADE: 09-DEC-11 WATERTOWN MA 02471 0780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATB ADVANCE PTA DILATATION CATHETER COOK, INC. 510(k) NO: K113300(SPECIAL) ATTN: ELYSIA POOR PHONE NO : 812 339 2235 750 DANIELS WAY SE DECISION MADE: 09-DEC-11 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSLEOBRIDGE IDSF SPACER CONECTOR MERETE MEDICAL GMBH 510(k) NO: K113303(SPECIAL) ATTN: EMMANUEL ANAPLIOIS PHONE NO : 490 307 799800 102 ALT LANKWITZ SE DECISION MADE: 09-DEC-11 BERLIN GM D-12247 510(k) STATEMENT DEVICE: EVOLUTION MP ADAPTIVE CS INSERT WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K113325(SPECIAL) ATTN: DANIELLE MUELLER PHONE NO : 901 290 5904 5677 AIRLINE RD. SE DECISION MADE: 09-DEC-11 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SI-LOK SACROILIAC JOINT FIXATION SYSTEM GLOBUS MEDICAL, INC. 510(k) NO: K112028(TRADITIONAL) ATTN: WENDY S HILLS PHONE NO : 610 930 1800 2560 GENERAL ARMISTEAD AVE. VALLEYSE DECISION MADE: 09-DEC-11 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRESAGE ST2 ASSAY CRITICAL CARE DIAGNOSTICS, INC. (D510(k) NO: K111452(TRADITIONAL) ATTN: JAMES SNIDER PHONE NO : 858 270 2400 3030 BUNKER HILL STREET SUITE 115ASE DECISION MADE: 09-DEC-11 SAN DIEGO CA 92109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NETKONNECT REMOTE NETWORK EXTENSION NIHON KOHDEN 510(k) NO: K112637(SPECIAL) ATTN: STEVE GEERDES PHONE NO : 949 580 1555 90 ICON SE DECISION MADE: 09-DEC-11 FOOTHILL RANCH CA 92610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBONY PTA 0.014" PERIPHERAL DILATATION CATHETER NATEC MEDICAL LTD 510(k) NO: K112513(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 888 729 9674 1468 HARWELL AVENUE SE DECISION MADE: 09-DEC-11 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO ANDON HEALTH CO., LTD 510(k) NO: K111830(SPECIAL) ATTN: LIU YI PHONE NO : 86 22 60526161 No. 3 Jin Ping Street,Ya An Ro NANSE DECISION MADE: 09-DEC-11 TIANJIN CN 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELLTRACKS ANALYER II VERIDEX, LLC 510(k) NO: K113181(SPECIAL) ATTN: PATRICIA HOJNOSKI PHONE NO : 908 595 2473 1001 US HIGHWAY 202 NORTH SE DECISION MADE: 12-DEC-11 RARITAN NJ 08869 0606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZEUS ELISA CARDIOLIPIN SCREEN TEST SYSTEM ZEUS SCIENTIFIC, INC. 510(k) NO: K102425(TRADITIONAL) ATTN: EWA NADOLCZAK PHONE NO : 908 526 3744 200 EVANS WAY SE DECISION MADE: 12-DEC-11 BRANCHBURG NJ 08876 510(k) STATEMENT DEVICE: ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING NUCLETRON 510(k) NO: K113102(TRADITIONAL) ATTN: MICHEAL PAUL PHONE NO : 443 545 2182 7021 Columbia Gateway Dr Suite SE DECISION MADE: 12-DEC-11 Columbia MD 21046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPACER-S TECRES SPA 510(k) NO: K112983(TRADITIONAL) ATTN: CHRISTINE BRAUER PHONE NO : 301 545 1990 7 TRAIL HOUSE COURT SE DECISION MADE: 12-DEC-11 ROCKVILLE MD 20850 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCULIF TL CAGE COALIGN INNOVATIONS, INC. 510(k) NO: K113465(SPECIAL) ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800 1331 H STREET NW 12TH FLOOR SE DECISION MADE: 12-DEC-11 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOLOC 3DSI LOCKING SCREWS WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K113339(SPECIAL) ATTN: PEGGY S RIVERS PHONE NO : 901 867 4759 5677 AIRLINE RD. SE DECISION MADE: 12-DEC-11 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARROW-LOK DIGITAL SYSTEM ARROWHEAD MEDICAL DEVICE TECHNOLOG510(k) NO: K112675(TRADITIONAL) ATTN: THOMAS J TWARDZIK PHONE NO : 901 853 4366 328 POPLAR VIEW LANE EAST SUITE 2 SE DECISION MADE: 12-DEC-11 COLLIERVILLE TN 38017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XINGTM SPINE SYSTEM IMPLANOVA CO. LTD 510(k) NO: K111995(TRADITIONAL) ATTN: APRIL LEE PHONE NO : 714 525 0114 325 N. PUENTE ST UNIT B SE DECISION MADE: 12-DEC-11 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOSPRING FOOTJACK SUBTALAR IMPLANT SYSTEM OSTEOSPRING MEDICAL, INC 510(k) NO: K112658(TRADITIONAL) ATTN: J.D. WEBB PHONE NO : 512 388 0199 228 HAMILTON AVENUE, 3RD FLOOR SE DECISION MADE: 12-DEC-11 PALO ALTO CA 94301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES ZERO-P SYNTHES SPINE CO.LP 510(k) NO: K112459(SPECIAL) ATTN: STACEY BONNELL PHONE NO : 610 719 5895 1302 WRIGHTS LANE EAST SE DECISION MADE: 12-DEC-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISION SKIN EMULSION PRECISION DERMATOLOGY INCORPORATED510(k) NO: K111168(TRADITIONAL) ATTN: RONALD M GURGE, PH.D PHONE NO : 401 762 2000 900 HIGHLAND CORPORATE DRIVE SE DECISION MADE: 13-DEC-11 CUMBERLAND RI 02864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES OMEGA LABORATORIES, INC. 510(k) NO: K103161(TRADITIONAL) ATTN: ROBERT J BARD, JD PHONE NO : 248 563 5040 400 NORTH CLEVELAND SE DECISION MADE: 13-DEC-11 MOGADORE OH 44260 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VBB SYSTEM SYNTHES 510(k) NO: K110604(TRADITIONAL) ATTN: JASON LIPMAN PHONE NO : 610 719 5629 1302 WRIGHTS LANE EAST SE DECISION MADE: 13-DEC-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEADLESS COMPRESSION SCREW SKELETAL DYNAMICS, LLC 510(k) NO: K112672(TRADITIONAL) ATTN: ANA M ESCAGEDO PHONE NO : 305 596 7585 8905 SW 87 AVENUE, SUITE 201 SE DECISION MADE: 13-DEC-11 MIAMI FL 33176 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TARGET DETACHABLE COIL STRYKER NEUROVASCULAR 510(k) NO: K113412(SPECIAL) ATTN: RHODA SANTOS PHONE NO : 510 413 2269 47900 BAYSIDE PARKWAY SE DECISION MADE: 13-DEC-11 FREMONT CA 94538 6515 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES HEMOSTATIC BONE PUTTY SYNTHES (USA) PRODUCTS LLC/NORIAN 510(k) NO: K113079(TRADITIONAL) ATTN: JEFFREY L DOW PHONE NO : 484 356 9720 1230 Wilson Dr SE DECISION MADE: 13-DEC-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM GE HEALTHCARE 510(k) NO: K113034(TRADITIONAL) ATTN: CAROL ALLOIAN PHONE NO : 847 244 8327 9900 INNOVATION DRIVE SE DECISION MADE: 13-DEC-11 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERFACE BONE VOID FILLER BIOSTRUCTURES, LLC 510(k) NO: K112857(TRADITIONAL) ATTN: KEVIN A THOMAS PHONE NO : 858 792 1235 11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 13-DEC-11 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COUGAR SYSTEM JOHNSON & JOHNSON 510(k) NO: K113348(SPECIAL) ATTN: KEVIN G STEVENS PHONE NO : 508 977 6445 325 PARAMOUNT DRIVE SE DECISION MADE: 13-DEC-11 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAXX(R) XD SYSTEM SPINE WAVE, INC. 510(k) NO: K111418(TRADITIONAL) ATTN: ROAIDA RIZKALLAH PHONE NO : 203 944 9494 3 ENTERPRISE DR SUITE 210 SE DECISION MADE: 13-DEC-11 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIEW 1 IMAGING KARL STORZ ENDOSCOPY AMERICA, INC.510(k) NO: K112480(TRADITIONAL) ATTN: WINKIE WONG PHONE NO : 424 218 8379 2151 E. GRAND AVENUE SE DECISION MADE: 13-DEC-11 EL SEGUNDO CA 90245 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMNOBRUX SPLINTS SOMNOMED INC 510(k) NO: K102909(TRADITIONAL) ATTN: BRADLEY SOUTHWORTH PHONE NO : 940 381 5200 7460 WARREN PARKWAY SUITE 190 SE DECISION MADE: 13-DEC-11 FRISCO TX 75034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PSM LOMAS / BENEFIT SCREWS PSM MEDICAL SOLUTIONS 510(k) NO: K110392(TRADITIONAL) ATTN: ANDREA PECSI PHONE NO : 004 974 62924051 SCHWARZWALDSTRASSE 5 SE DECISION MADE: 14-DEC-11 TUTTLINGEN BW GM 78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE ALCAVIS HDC LLC 510(k) NO: K111313(TRADITIONAL) ATTN: GARY J MISHKIN PHONE NO : 301 330 7597 8322 Helgerman CT SE DECISION MADE: 14-DEC-11 Gaithersburg MD 20877 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMI CARDIOVASCULAR PACH SOLIMAS MEDICAL, INC. 510(k) NO: K112683(TRADITIONAL) ATTN: MICHEAL KOLBE PHONE NO : 408 505 6626 443 COSTA MESA TERRACE SE DECISION MADE: 14-DEC-11 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TERUMO ASPRIATION CATHETER TERUMO MEDICAL CORPORATION 510(k) NO: K112382(TRADITIONAL) ATTN: DANIEL R PLONSKI PHONE NO : 410 392 7395 950 ELKTON BLVD SE DECISION MADE: 14-DEC-11 ELKTON MD 21921 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014" AND 0.018") TRIREME MEDICAL, INC. 510(k) NO: K111738(SPECIAL) ATTN: SHIVA ARDAKAMI PHONE NO : 925 931 1300 7060 Koll Center Parkway Suite 300SE DECISION MADE: 14-DEC-11 Pleasanton CA 94566 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: KDL SYRINGES AND NEEDLE SHANGHAI KINDLY ENTERPRISE DEV. GR510(k) NO: K112057(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 164 264467 P.O. BOX 237-023 SE DECISION MADE: 14-DEC-11 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENUS PEARL PLT REFILL A1 HERAEUS KULZER, LLC 510(k) NO: K112501(TRADITIONAL) ATTN: CHERYL ZIMMERMAN PHONE NO : 574 299 5444 300 HERAEUS WAY SE DECISION MADE: 14-DEC-11 SOUTH BEND IN 46614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4-WEB ALIF SPINAL TRUSS SYSTEM (STS) 4-WEB, INC. 510(k) NO: K112316(SPECIAL) ATTN: RICH JANSEN, PHARM. D. PHONE NO : 612 281 5505 13540 GUILD AVE. SE DECISION MADE: 14-DEC-11 APPLE VALLEY MN 55124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST MIRADOR BIOMEDICAL, INC. 510(k) NO: K112203(TRADITIONAL) ATTN: JUSTIN HULVERSHORN PHONE NO : 206 295 3372 2815 WASTLAKE AVENUE SUITE 220 SE DECISION MADE: 14-DEC-11 SEATTLE WA 98102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAPERED SCREW-VENT X IMPLANT ZIMMER DENTAL INC. 510(k) NO: K112160(TRADITIONAL) ATTN: JEREMY MARKOVICH PHONE NO : 760 929 4335 1900 ASTON AVE. SE DECISION MADE: 14-DEC-11 CARLSBAD CA 92008 7308 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K111753(TRADITIONAL) ATTN: ERIKA B AMMIRATI, RAC, MT (APHONE NO : 650 949 2768 575 SHIRLYNN COURT SE DECISION MADE: 14-DEC-11 LOS ALTOS CA 94022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRAMAXO2 OXYGEN ANALYER MAXTEC, LLC 510(k) NO: K112402(ABBREVIATED) ATTN: TAMMY LAVERY PHONE NO : 801 266 5300 6526 Cottonwood St # 300 SE DECISION MADE: 14-DEC-11 Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LANCER PEDICLE SCREW SYSTEM SPINAL SOLUTIONS, LLC 510(k) NO: K110633(SPECIAL) ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD SE DECISION MADE: 15-DEC-11 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K112275(SPECIAL) ATTN: LINDA KO PHONE NO : 886 266 258188 3F,5F, NO.127 WUGONG 2ND RD, WUGU SE DECISION MADE: 15-DEC-11 NEW TAIPEI CITY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRAORAL BELSENSOR GOLD TAKARA BELMONT USA, INC. 510(k) NO: K102456(TRADITIONAL) ATTN: ROBERT SCHIFF PHONE NO : 973 227 1830 1129 BLOOMFIELD AVENUE SE DECISION MADE: 15-DEC-11 WEST CALDWELL NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX BIOCOMPOSITE TRANSFIX ARTHREX, INC. 510(k) NO: K112040(SPECIAL) ATTN: SALLY FOUST PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 15-DEC-11 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE MEDRAD, INC. 510(k) NO: K113133(SPECIAL) ATTN: MIKE BURNSIDE PHONE NO : 763 717 1077 ONE MEDRAD DRIVE SE DECISION MADE: 15-DEC-11 INDIANOLA PA 15051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) BIOMET, INC. 510(k) NO: K111746(TRADITIONAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 574 267 6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 15-DEC-11 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APTUS(R) DISTAL HUMERUS SYSTEM MEDARTIS AG 510(k) NO: K112560(TRADITIONAL) ATTN: KEVIN A THOMAS PHONE NO : 858 792 1235 11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 15-DEC-11 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER KIMBERLY-CLARK 510(k) NO: K112562(TRADITIONAL) ATTN: DAVID LEE PHONE NO : 770 587 7167 1400 HOLCOMB BRIDGE ROAD SE DECISION MADE: 15-DEC-11 ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. 510(k) NO: K112780(TRADITIONAL) ATTN: AMITA S SHAH PHONE NO : 781 345 9164 11 NORTH AVENUE SE DECISION MADE: 15-DEC-11 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROG SUTURE ANCHOR ROG SPORTS MEDICINE, INC. 510(k) NO: K113299(SPECIAL) ATTN: CURTIS RAYMOND PHONE NO : 203 922 0105 80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 15-DEC-11 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXASLT T7 WOUND DRESSING EXCITON TECHNOLOGIES INC. 510(k) NO: K113564(SPECIAL) ATTN: MELANIE USSYK PHONE NO : 780 248 5868 Suite 4000 10230 Jasper Avenue SE DECISION MADE: 15-DEC-11 Edmonton CA T5J 4P6 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE PANPAC MEDICAL CORPORATION 510(k) NO: K102898(TRADITIONAL) ATTN: YEN-MING PAN PHONE NO : 886 286 472242 NO. 202, 6F-1.2, SEC.3 TATONG ROADSE DECISION MADE: 15-DEC-11 SHI-CHIH CITY, TAIPEI HSIEN TW 510(k) STATEMENT DEVICE: PICO SMITH & NEPHEW, INC. 510(k) NO: K111170(TRADITIONAL) ATTN: TERRY MCMAHON PHONE NO : 727 392 1261 970 LAKE CARILLON DR. SUITE 110 SE DECISION MADE: 15-DEC-11 ST. PETERSBURG FL 33716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMPUSIC PATIENT MONITOR REMOTE DIAGNOSTIC TECHNOLOGIES LTD510(k) NO: K113105(ABBREVIATED) ATTN: CHRIS HANNAN PHONE NO : 441 256 362400 THE OLD COACH HOUSE, THE AV. FARLESE DECISION MADE: 15-DEC-11 HAMPSHIRE UK RG25 2HT 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS INSULET CORPORATION 510(k) NO: K111669(TRADITIONAL) ATTN: SUSAN FINNERAN PHONE NO : 781 457 5234 9 OAK PARK DR. SE DECISION MADE: 15-DEC-11 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K112218(TRADITIONAL) ATTN: SUZANA OTANO PHONE NO : 305 269 6386 700 ORTHOPAEDIC DRIVE SE DECISION MADE: 15-DEC-11 WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MSA HIP SYSTEM GLOBAL MANUFACTURING TECHNOLOGY 510(k) NO: K113107(SPECIAL) ATTN: HOLLACE S RHODES PHONE NO : 202 552 5800 1331 H STREET NW SE DECISION MADE: 15-DEC-11 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5 CAYENNE MEDICAL, INC. 510(k) NO: K112876(TRADITIONAL) ATTN: KERESHMEH SHAHRIARI PHONE NO : 480 502 3661 16597 N. 92ND STREET SUITE 101 SE DECISION MADE: 15-DEC-11 SCOTTSDALE AZ 85260 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUIDEL MOLECULAR HMPV ASSAY QUIDEL CORP. 510(k) NO: K112490(TRADITIONAL) ATTN: RONALD H LOLLAR PHONE NO : 858 552 1100 10165 MCKELLAR CT. SE DECISION MADE: 15-DEC-11 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 B-K MEDICAL APS 510(k) NO: K100919(TRADITIONAL) ATTN: RANDI HAUERBERG PHONE NO : 454 452 8105 MILEPARKEN 34 SE DECISION MADE: 16-DEC-11 HERLEV DA DK-2730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASONIC SURGICAL UNIT DONG IL TECHNOLOGY LTD. 510(k) NO: K110881(TRADITIONAL) ATTN: PETER CHUNG PHONE NO : 412 687 3976 300 ATWOOD SE DECISION MADE: 16-DEC-11 PITTSBURGH PA 15213 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MED GRAVITY SET, IMED PUMP SET IMED TECHNOLOGY, INC. 510(k) NO: K102712(TRADITIONAL) ATTN: BRANDON CONVERSE PHONE NO : 785 317 0722 17408 TAMARON DRIVE SE DECISION MADE: 16-DEC-11 DALLAS TX 75287 510(k) STATEMENT DEVICE: HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS) I.E.M. GMBH 510(k) NO: K110603(TRADITIONAL) ATTN: PETER KNIPP PHONE NO : 49 240 29500-0 COCKERILLSTRASSE 69 SE DECISION MADE: 16-DEC-11 STOLBERG GM 52222 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K110360(TRADITIONAL) ATTN: SARAH HOLTGREWE PHONE NO : 901 867 4476 5677 AIRLINE RD. SE DECISION MADE: 16-DEC-11 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LANX CERVICAL SA LANX, INC 510(k) NO: K112388(TRADITIONAL) ATTN: MICHAEL FUNK PHONE NO : 303 443 7500 310 INTERLOCKEN PARKWAY, SUITE 120SE DECISION MADE: 16-DEC-11 BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUIBAND FLOW CONTROL MEDLOGIC GLOBAL LIMITED 510(k) NO: K110184(TRADITIONAL) ATTN: MICHAEL BROWNE PHONE NO : 004 417 52209955 WESTERN WOOD WAY LANGAGE SCIENCE PSE DECISION MADE: 16-DEC-11 PLYMOUTH, DEVON UK PL7 5BG 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: "AMECATH" AND "AMECATH UNIQATH SOFT" SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS AMECO MEDICAL INDUSTRIES 510(k) NO: K110793(TRADITIONAL) ATTN: RAY KELLY PHONE NO : 603 809 7668 79 BROOKLINE ROAD SE DECISION MADE: 16-DEC-11 MASON NH 03048 510(k) STATEMENT DEVICE: INTEGRITY(TM) ELEKTA LIMITED 510(k) NO: K112613(TRADITIONAL) ATTN: ANDREW HEDGES PHONE NO : 44 129 3654201 LINAC HOUSE SE DECISION MADE: 16-DEC-11 CRAWLEY, WEST SUSSEX UK RH10 9R510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT NOVABONE PRODUCTS, LLC 510(k) NO: K112428(TRADITIONAL) ATTN: DAVID M GAISSER PHONE NO : 386 462 7661 13631 PROGRESS BLVD SUITE 600 SE DECISION MADE: 16-DEC-11 ALACHUA FL 32615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) NANOSPHERE, INC 510(k) NO: K112424(TRADITIONAL) ATTN: MARK DEL VECCHIO PHONE NO : 847 400 9000 4088 COMMERCIAL AVENUE SE DECISION MADE: 16-DEC-11 NORTHBROOK IL 60062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW XIAMEN DOUBLE ENGLINE MEDICAL MATE510(k) NO: K112819(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 122 815850 P.O. BOX 237-023 SE DECISION MADE: 16-DEC-11 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPREHENSIVE REVERSE SHOULDER BIOMET MANUFACTURING, INC. 510(k) NO: K113121(SPECIAL) ATTN: PATRICIA S BERES PHONE NO : 574 267 6639 56 EAST BELL DR. SE DECISION MADE: 16-DEC-11 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANSPACH DISSECTION TOOLS THE ANSPACH EFFORT, INC. 510(k) NO: K113476(SPECIAL) ATTN: JEANNETTE G DAILEY PHONE NO : 561 627 1080 4500 RIVERSIDE DR. SE DECISION MADE: 16-DEC-11 Palm Bch Gdns FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMSCO CHIMERON MEDIUM STEAM STERILIZER STERIS CORPORATION 510(k) NO: K112055(TRADITIONAL) ATTN: ROBERT F SULLIVAN PHONE NO : 440 392 7695 5960 HEISLEY ROAD SE DECISION MADE: 16-DEC-11 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM BIOLITEC MEDICAL DEVICES, INC 510(k) NO: K112987(TRADITIONAL) ATTN: HARY HAYES PHONE NO : 413 250 0779 1349 MAIN ROAD SE DECISION MADE: 16-DEC-11 GRANDVILLE MA 01034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K113647(TRADITIONAL) ATTN: ZHAI PEI PHONE NO : 867 552 6582551 MINDRAY BUILDING, KEJI 12TH RD SOUSE DECISION MADE: 16-DEC-11 NANSHAN,SHENZHEN, P.R. CHINA CH510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GE DATEX-OHMEDA AVANCE DATEX-OHMEDA, INC. 510(k) NO: K112722(TRADITIONAL) ATTN: JIM RASKOB PHONE NO : 608 221 1551 PO BOX 7550 SE DECISION MADE: 16-DEC-11 MADISON WI 53707 7550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT EXAMINATION GLOVE SUQIAN RUIJANG MEDICAL SUPPLIES CO510(k) NO: K113193(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 1 JIAN XIANG YUAN NO. 209 BEI SI HSE DECISION MADE: 16-DEC-11 CHU XIAOAN CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. 510(k) NO: K113457(SPECIAL) ATTN: LARAINE PANGELINA PHONE NO : 714 247 8000 1311 VALENCIA AVE SE DECISION MADE: 16-DEC-11 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIRLIGHT DENTAL HANDPIECE BEYES DENTAL CANADA INC 510(k) NO: K112623(TRADITIONAL) ATTN: ANTHONY HOPKINS PHONE NO : 877 202 1588 3500 SOUTH DUPONT HIGHWAY SE DECISION MADE: 16-DEC-11 DOVER DE 19901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTINCT JAVA SYSTEM ZIMMER SPINE 510(k) NO: K113270(TRADITIONAL) ATTN: ELSA A LINKE PHONE NO : 952 830 6205 7375 BUSH LAKE ROAD SE DECISION MADE: 16-DEC-11 EDINA MN 55439 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMUNOCARD C. DIFFICILE GDH MERIDIAN BIOSCIENCE, INC. 510(k) NO: K112048(TRADITIONAL) ATTN: SUSAN BOGAR PHONE NO : 513 271 3700 3471 RIVER HILLS DR. SE DECISION MADE: 16-DEC-11 CINCINNATI OH 45244 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPOTLIGHT ACCESS SYSTEM JOHNSON & JOHNSON 510(k) NO: K112913(SPECIAL) ATTN: LAURA BLEYENDAAL PHONE NO : 508 828 3267 325 PARAMOUNT DRIVE SE DECISION MADE: 16-DEC-11 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TINNITUS THERAPY SYSTEM ANM T30 CR ANM ADAPTIVE NEUROMODULATION GMBH 510(k) NO: K112752(TRADITIONAL) ATTN: INGRID ROHM PHONE NO : 49 221 4546300 IM MEDIAPARK 6D SE DECISION MADE: 16-DEC-11 KOLN GM D-50670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REMSTAR AUTO A-FLEX HT RESPIRONICS, INC. 510(k) NO: K113068(SPECIAL) ATTN: FRANK KADI PHONE NO : 724 387 4134 1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 16-DEC-11 MONROEVILLE PA 15146 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE THERMOMETER COVERS AND SHEATHS KANG ZE INDUSTRIAL CO. LIMITED 510(k) NO: K112289(TRADITIONAL) ATTN: DORIS DONG PHONE NO : 86 213 1261348 RM 1706 YUESHA BLDG NO 128 SONGLE SE DECISION MADE: 16-DEC-11 SONGJIANG AREA, SHANGHAI CH 201510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SBV2, MULTICHARGER MODEL MC10V2 SLEEP PERFORMANCE D.B.A. FATIGUE S510(k) NO: K111514(TRADITIONAL) ATTN: MARC GOODMAN PHONE NO : 949 398 5222 5405 ALTON PARKWAY SUITE A530 SE DECISION MADE: 16-DEC-11 IRVINE CA 92604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIXATE TISSUE BAND ANULEX TECHNOLOGIES, INC 510(k) NO: K113400(SPECIAL) ATTN: RACHEL KENNEDY PHONE NO : 952 224 4000 5600 ROWLAND ROAD, STE 280 SE DECISION MADE: 16-DEC-11 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ER35 ERO-SCAN PRO HEARING TEST SYSTEM ETYMOTIC RESEARCH, INC. 510(k) NO: K112733(TRADITIONAL) ATTN: JACK KENT PHONE NO : 202 822 1850 2001 PENNSYLVANIA AVE. NW SUITE 95SE DECISION MADE: 16-DEC-11 WASHINGTON DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL CLEAN MEDICAL MANFACTURING CO;LTD 510(k) NO: K112743(TRADITIONAL) ATTN: AARON RICHARD PHONE NO : 626 964 1000 18633 E. GALE AVE.#105 SE DECISION MADE: 16-DEC-11 CITY OF INDUSTRY CA 91748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400 BEYES DENTAL CANADA INC 510(k) NO: K112869(TRADITIONAL) ATTN: ANTHONY HOPKINS PHONE NO : 877 202 1588 3500 SOUTH DUPONT HIGHWAY SE DECISION MADE: 16-DEC-11 DOVER DE 19901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER NINEPOINT MEDICAL, INC 510(k) NO: K112770(TRADITIONAL) ATTN: CINDY DOMECUS PHONE NO : 650 343 4813 1171 BARROIHET AVENUE SE DECISION MADE: 16-DEC-11 HILLSBOROUGH CA 94010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARSTART SVM SYSTEM INTIO INC. 510(k) NO: K113541(TRADITIONAL) ATTN: DAVID GUSTAFSON PHONE NO : 303 800 3700 325 INTERLOCKEN PARKWAY SE DECISION MADE: 16-DEC-11 BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ONDEMAND3D CYBERMED, INC. 510(k) NO: K113543(TRADITIONAL) ATTN: YONG KI IM PHONE NO : 822 339 73970 #504 SJ TECHNOVILLE, GASAN-DONG 60SE DECISION MADE: 16-DEC-11 SEOUL KS 153-710 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HD-IVUS ULTRASOUND IMAGING SYSTEM SILICON VALLY MEDICAL INSTRUMENTS,510(k) NO: K112997(TRADITIONAL) ATTN: RICHARD E ANDERSON PHONE NO : 510 897 4695 47697 WESTINGHOUSE SUITE 101 SE DECISION MADE: 17-DEC-11 FREMONT CA 94539 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 8MP COLOR LCD MONITOR,RADIFORCE RX840 EIZO NANAO CORPORATION 510(k) NO: K113226(TRADITIONAL) ATTN: HIROAKI HASHIMOTO PHONE NO : 81 76 2742468 153 SHIMOKASHIWANO, SE DECISION MADE: 17-DEC-11 HAKUSAN, ISHIKAWA JA 924-8566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOGRAPH MCT FAMILY SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K113448(SPECIAL) ATTN: ALAINE MEDIO PHONE NO : 865 218 2703 810 INNOVATION DR. SE DECISION MADE: 17-DEC-11 KNOXVILLE TN 37932 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS ORTHO SOLUTIONS LIMITED 510(k) NO: K110895(TRADITIONAL) ATTN: AL LIPPINCOTT PHONE NO : 952 492 5858 3150 E. 200TH STREET SE DECISION MADE: 19-DEC-11 PRIOR LAKE MN 55372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACEM SANDHILL SCIENTIFIC, INC. 510(k) NO: K111013(TRADITIONAL) ATTN: LEWIS WARD PHONE NO : 303 530 3279 4655 KIRKWOOD CT SE DECISION MADE: 19-DEC-11 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOFACT VIII R2 DIAGNOSTICS, INC. 510(k) NO: K102851(TRADITIONAL) ATTN: MARC D GOLDFORD PHONE NO : 574 288 4377 1801 COMMERCE DR. SE DECISION MADE: 19-DEC-11 SOUTH BEND IN 46628 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOFACT IX R2 DIAGNOSTICS, INC. 510(k) NO: K102908(TRADITIONAL) ATTN: MARC D GOLDFORD PHONE NO : 574 288 4377 1801 COMMERCE DR. SE DECISION MADE: 19-DEC-11 SOUTH BEND IN 46628 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY ZIMMER, INC. 510(k) NO: K112885(TRADITIONAL) ATTN: STEPHEN H MCKELVEY PHONE NO : 574 372 4944 P.O. BOX 708 SE DECISION MADE: 19-DEC-11 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) AXIS-SHIELD DIAGNOSTICS, LTD. 510(k) NO: K112443(TRADITIONAL) ATTN: CLAIRE I DORA PHONE NO : 044 138 2422000 THE TECHNOLOGY PARK LUNA PLACE SE DECISION MADE: 19-DEC-11 DUNDEE, UK DD2 1XA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K112587(TRADITIONAL) ATTN: REBECCA ANDERSEN PHONE NO : 734 741 6113 6200 JACKSON RD. SE DECISION MADE: 19-DEC-11 ANN ARBOR MI 48103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXSOS LOCKING PLATE SYSTEM STRYKER CORP. 510(k) NO: K112926(TRADITIONAL) ATTN: KELLY KUCHARCZYK PHONE NO : 201 831 6455 325 CORPORATE DRIVE SE DECISION MADE: 19-DEC-11 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDACTA-C MEDACTA INTERNATIONAL 510(k) NO: K112862(TRADITIONAL) ATTN: ADAM GROSS PHONE NO : 805 437 7085 4725 CALLE QUETZAL, UNIT B SE DECISION MADE: 19-DEC-11 CAMARILLO CA 93012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MX-7000 MICROXEL BIO-MED U.S.A., INC. 510(k) NO: K111831(TRADITIONAL) ATTN: YOUNG CHI PHONE NO : 973 278 5222 111 ELLISON ST. SE DECISION MADE: 19-DEC-11 PATERSON NJ 07505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) LANX, INC. 510(k) NO: K113434(SPECIAL) ATTN: MICHAEL FUNK PHONE NO : 303 443 7500 210 INTERLOCKEN PARKWAY SUITE 120 SE DECISION MADE: 19-DEC-11 BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE ARTHREX, INC. 510(k) NO: K112990(TRADITIONAL) ATTN: CHRISTINA FLORES PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 19-DEC-11 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIPIFLOW THERMAL PULSATION SYSTEM TEARSCIENCE, INC. 510(k) NO: K112704(TRADITIONAL) ATTN: CHRISTY STEVENS PHONE NO : 919 467 4007 5151 MCCRIMMON PARKWAY SUITE 250 SE DECISION MADE: 19-DEC-11 MORRISVILLE NC 27560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ETHICON ENDO-SURGERY, LLC 510(k) NO: K112056(TRADITIONAL) ATTN: ASIFA VONHOF PHONE NO : 513 337 3118 4545 CREEK ROAD SE DECISION MADE: 19-DEC-11 CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K101926(TRADITIONAL) ATTN: LINDA KO PHONE NO : 886 2 66258188 3F,5F, NO.127 WUGONG 2ND RD. WUGU SE DECISION MADE: 20-DEC-11 TAIPEI COUNTY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES BEMA-GMBH & CO. KG 510(k) NO: K102921(TRADITIONAL) ATTN: ANGELIKA SCHERP PHONE NO : 011 312 06125626 AMSTEL 320-1 SE DECISION MADE: 20-DEC-11 AMSTERDAM, NOORD-HOLLAND NL 101510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNMIAX LAPAROSCOPIC INSTRUMENT UNIMAX MEDICAL SYSTEMS, INC. 510(k) NO: K103508(TRADITIONAL) ATTN: MICHAEL LEE PHONE NO : 886 228 096995 NO. 45, MINSHEN RD. DANSHUI TOWN SE DECISION MADE: 20-DEC-11 TAIPEI COUNTY TW 251 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICHELE SLEEP SCORING SYSTEMS YOUNES SLEEP TECHNOLOGIES 510(k) NO: K112102(TRADITIONAL) ATTN: MAGDY YOUNES PHONE NO : 204 943 6295 435 ELLICE AVENUE SE DECISION MADE: 20-DEC-11 WINNIPEG, MANITOBA CA R3B 1Y6 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS SMITH & NEPHEW, INC. 510(k) NO: K112941(ABBREVIATED) ATTN: DAVID HENLEY PHONE NO : 901 399 6487 7135 GOODLETT FARMS PARKWAY SE DECISION MADE: 20-DEC-11 CORDOVA TN 38016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE ABBOTT PONT OF CARE INC 510(k) NO: K112430(TRADITIONAL) ATTN: YUKO HARTLEY PHONE NO : 609 454 9271 400 COLLEGE ROAD EAST SE DECISION MADE: 20-DEC-11 PRINCETON NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUOFERTILITY CAMBRIDGE TEMPERATURE CONCEPTS LTD510(k) NO: K102499(TRADITIONAL) ATTN: SCOTT R MACKIE PHONE NO : 617 803 1026 P.O. BOX 390930 SE DECISION MADE: 20-DEC-11 CAMBRIDGE MA 02139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IFS SUBTALAR IMPLANT INTERNAL FIXATION SYSTEMS, INC. 510(k) NO: K113399(TRADITIONAL) ATTN: CHRIS ENDARA PHONE NO : 305 884 5993 10100 N.W. 116TH WAY, STE. 18 SE DECISION MADE: 20-DEC-11 MIAMI FL 33178 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIRECT ANTIBIOTIC INFUSION KIT SUMMIT MEDICAL PRODUCTS, INC 510(k) NO: K113043(TRADITIONAL) ATTN: MARKO V AMEN PHONE NO : 801 352 1888 2480 S Main St Ste 212 SE DECISION MADE: 20-DEC-11 Salt Lake Cty UT 84115 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELM PTA BALLON DILATATION CATHETER CREAGH MEDICAL LTD 510(k) NO: K113468(SPECIAL) ATTN: MAUREEN O'CONNELL PHONE NO : 978 207 1245 5 TIMBER LANE SE DECISION MADE: 20-DEC-11 NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEALIX KNOTLESS ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K113534(SPECIAL) ATTN: DEEP PAL PHONE NO : 508 977 3998 325 PARAMOUNT DR. SE DECISION MADE: 20-DEC-11 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KIM NEOMEDIC INTERNATIONAL S.L. 510(k) NO: K103022(TRADITIONAL) ATTN: JEFFREY R SHIDEMAN PHONE NO : 952 835 4018 7307 GLOUCHESTER DRIVE SE DECISION MADE: 20-DEC-11 EDINA MN 55435 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PDS(TM) BARBED SUTURES ETHICON, INC. 510(k) NO: K113004(TRADITIONAL) ATTN: PETER CECCHINI PHONE NO : 908 218 2457 ROUTE 22 WEST P.O. BOX 151 SE DECISION MADE: 20-DEC-11 SOMERVILLE NJ 08876 0151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLYDESDALE(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K113528(SPECIAL) ATTN: BECKY RONNER PHONE NO : 901 399 2757 1800 PYRAMID PLACE SE DECISION MADE: 20-DEC-11 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS MEDISISS 510(k) NO: K113028(TRADITIONAL) ATTN: JOYCE ELKINS PHONE NO : 541 923 3310 2747 SW 6TH STREET SE DECISION MADE: 20-DEC-11 REDMOND OR 97756 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256) TOTOKU ELECTRIC CO., LTD 510(k) NO: K113136(TRADITIONAL) ATTN: TSUKASA TASHIRO PHONE NO : 81 258 246611 300 OYA SE DECISION MADE: 20-DEC-11 UEDA, NAGANO JA 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWER-LOAD COT FASTENER SYSTEM STRYKER MEDICAL 510(k) NO: K113598(TRADITIONAL) ATTN: RENATA SILA PHONE NO : 269 389 6689 3800 E. CENTRE AVE. SE DECISION MADE: 20-DEC-11 PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: METRON-CP/MD EPONATECH LLC 510(k) NO: K103554(ABBREVIATED) ATTN: K. BRIAN MATLOCK PHONE NO : 925 944 7131 1485 TREAT BOULEVARD SUITE 200 SE DECISION MADE: 20-DEC-11 WALNUT CREEK CA 94597 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIMACORPORATE SMR REVERSE SHOULDER SYSTEM LIMACORPORATE S.P.A. 510(k) NO: K113523(SPECIAL) ATTN: CHERYL HASTINGS PHONE NO : 574 527 4220 P.O. BOX 696 SE DECISION MADE: 20-DEC-11 WINONA LAKE IN 46590 696 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM ABBOTT MEDICAL OPTICS INC 510(k) NO: K111446(TRADITIONAL) ATTN: ROSANNE M YETEMIAN PHONE NO : 714 247 8282 1700 EAST SAINT ANDREW PL SE DECISION MADE: 21-DEC-11 SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GALAXY SYSTEM; JUPITER PERSONAL HEALTH INSTITUTE INTERNAT510(k) NO: K111055(TRADITIONAL) ATTN: KUMAR KULKARNI PHONE NO : 263 CEDAR CREEK DRIVE SE DECISION MADE: 21-DEC-11 BATTLE CREEK MI 49015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: "AMECATH CVC" AND "AMECATH PRESSURE CVC" SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS AMECO MEDICAL INDUSTRIES 510(k) NO: K110794(TRADITIONAL) ATTN: RAY KELLY PHONE NO : 603 809 7668 79 BROOKLINE ROAD SE DECISION MADE: 21-DEC-11 MASON NH 03048 510(k) STATEMENT DEVICE: DERMATOLOGICAL TREATMENT DEVICE FAMILY SHARPLIGHT TECHNOLOGIES LTD. 510(k) NO: K111303(TRADITIONAL) ATTN: ILAN SHARON PHONE NO : 972 528 704904 P.O. BOX 4262 SE DECISION MADE: 21-DEC-11 ZICHRON YAACOV IS 30900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K112274(SPECIAL) ATTN: LINDA KO PHONE NO : 886 266 258188 3F, 5F, NO 127 WUGONG 2ND RD WUGU SE DECISION MADE: 21-DEC-11 NEW TAIPEI CITY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: N-HYBRIDE-COMPOSITE LC FLOW VOCO GMBH 510(k) NO: K113444(SPECIAL) ATTN: T. GERKENSMEIER PHONE NO : 494 721 719200 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 21-DEC-11 CUXHAVEN GM D-27472 510(k) STATEMENT DEVICE: ARTHREX FRACTURE SYSTEM ARTHREX, INC. 510(k) NO: K112437(TRADITIONAL) ATTN: COURTNEY SMITH PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 21-DEC-11 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYSENSE HEART CARDIAC SCIENCE CORPORATION 510(k) NO: K113176(TRADITIONAL) ATTN: NEIL SHELLER PHONE NO : 425 402 2156 3303 MONTE VILLA PKWY. SE DECISION MADE: 21-DEC-11 BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: N-HYBRIDE-COMPOSITE LC VOCO GMBH 510(k) NO: K113563(SPECIAL) ATTN: M.TH. PLAUMANN PHONE NO : 494 721 7190 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 21-DEC-11 CUXHAVEN GM D-27472 510(k) STATEMENT DEVICE: SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES SYNTHES INC 510(k) NO: K113251(SPECIAL) ATTN: ALAN HALEY PHONE NO : 484 356 9763 1302 GOSHEN PARKWAY SE DECISION MADE: 21-DEC-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FM-9000 PLUS FETAL AND MATERNAL MONITOR ADVANCED INSTRUMENTATIONS, INC. 510(k) NO: K112317(TRADITIONAL) ATTN: JORGE MILLAN PHONE NO : 305 925 1260 601 WEST 20 ST SE DECISION MADE: 21-DEC-11 HIALEAH FL 33010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANGE SPINAL SYSTEM (MESA AND DENALI) K2M, INC. 510(k) NO: K112920(SPECIAL) ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR.,SE SE DECISION MADE: 21-DEC-11 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES COOPER VISION, INC. 510(k) NO: K112302(TRADITIONAL) ATTN: LISA HAHN PHONE NO : 585 385 6810 6150 STONERIDGE MALL ROAD SE DECISION MADE: 21-DEC-11 PLEASANTON CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRESENIUS 2008T HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K113427(SPECIAL) ATTN: DENISE OPPERMANN PHONE NO : 781 699 4479 920 WINTER STREET SE DECISION MADE: 21-DEC-11 WALTHAM MA 02451 1457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUKUDA DENSHI VASERA MODEL VS-1500 FUKUDA DENSHI USA, INC. 510(k) NO: K112521(TRADITIONAL) ATTN: DOUG BLAKELY PHONE NO : 425 881 7737 17725 N.E. 65TH ST., BLDG. C SE DECISION MADE: 21-DEC-11 REDMOND WA 98052 4911 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIMEDICA CATALYS PRECISION LASER SYSTEM OPTIMEDICA CORPORATION 510(k) NO: K113479(TRADITIONAL) ATTN: ALAN MARQUARDT PHONE NO : 408 850 8600 3100 CORONADO DRIVE SE DECISION MADE: 21-DEC-11 SANTA CLARA CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TCX-I REMOTE CARE MANAGEMENT SYSTEM BL HEALTHCARE, INC. 510(k) NO: K113493(SPECIAL) ATTN: MICHEAL MATHUR PHONE NO : 508 543 4150 33 COMMERCIAL ST., SUITE #3 SE DECISION MADE: 21-DEC-11 FOXBORO MA 02035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMBRYO VIEWER SOFTWARE UNISENSE FERTILITECH A/S 510(k) NO: K113075(TRADITIONAL) ATTN: METTE MUNCH PHONE NO : 458 944 9500 TUEAGER 1 SE DECISION MADE: 21-DEC-11 ARRHUS N DA DK-8200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPRESS MULTI-SINUS DILATION TOOL ENTELLUS MEDICAL, INC. 510(k) NO: K112506(SPECIAL) ATTN: KAREN E PETERSON PHONE NO : 763 463 7066 6705 WEDGWOOD COURT NORTH SE DECISION MADE: 21-DEC-11 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUREFLO MONITORING SYSTEM TRANSONIC SYSTEMS, INC. 510(k) NO: K112657(TRADITIONAL) ATTN: DAVID KLEMENTOWSKI PHONE NO : 607 257 5300 34 DUTCH MILL RD. WARREN RD. BUSINSE DECISION MADE: 21-DEC-11 ITHACA NY 14850 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES MIRS SYNTHES SPINE 510(k) NO: K113044(TRADITIONAL) ATTN: HEATHER GUERIN PHONE NO : 610 719 5432 1302 WRIGHTS LN EAST SE DECISION MADE: 21-DEC-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELL-DYN EMERALD 22 SYSTEM ABBOT LABORATORIES 510(k) NO: K110381(TRADITIONAL) ATTN: MICHELLE B ROEDING PHONE NO : 408 982 4800 5440 PATRICK HENRY DR. SE DECISION MADE: 22-DEC-11 SANTA CLARA CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME CARDIO COMM SOLUTIONS, INC. 510(k) NO: K111159(TRADITIONAL) ATTN: JONATHAN WARD PHONE NO : 813 645 2855 962 ALLEGRO LANE SE DECISION MADE: 22-DEC-11 APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENOGRAPHE DS, SENOGRAPHE ESSENTIAL GENERAL ELECTRIC COMPANY 510(k) NO: K110798(TRADITIONAL) ATTN: STEVEN KACHELMEYER PHONE NO : 262 548 2432 3000 NORTH GRANDVIEW BLVD. SE DECISION MADE: 22-DEC-11 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELL-DYN 22 PLUS CALIBRATOR STRECK 510(k) NO: K111204(TRADITIONAL) ATTN: DEBORAH KIPP PHONE NO : 402 537 5215 7002 SOUTH 109TH ST. SE DECISION MADE: 22-DEC-11 OMAHA NE 68128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELL-DYN 22 PLUS CONTROL STRECK 510(k) NO: K111211(TRADITIONAL) ATTN: DEBORAH KIPP PHONE NO : 402 537 5215 7002 SOUTH 109TH ST. SE DECISION MADE: 22-DEC-11 OMAHA NE 68128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLUE SKY BIO TCP BLUE SKY BIO, LLC 510(k) NO: K110198(TRADITIONAL) ATTN: MICHELE VOVOLKA PHONE NO : 847 856 0355 888 E BELVIDERE RD. SUITE 212 SE DECISION MADE: 22-DEC-11 GRAYSLAKE IL 60030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KOO SMALL VOLUME NEBULIZER (SVN) KOO(SHANGHAI)INDUSTRIES CO., LTD. 510(k) NO: K112041(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 22-DEC-11 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PENCAN SPINAL NEEDLE B. BRAUN MEDICAL, INC. 510(k) NO: K112515(TRADITIONAL) ATTN: LISA GIAQUINTO PHONE NO : 610 596 0500 901 MARCON BLVD. SE DECISION MADE: 22-DEC-11 ALLENTOWN PA 18109 9341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARI-LASE WIREFIBER LASER FIBER VASCULAR SOLUTIONS, INC. 510(k) NO: K113140(SPECIAL) ATTN: JENIFER RUETHER PHONE NO : 763 656 4300 6464 SYCAMORE COURT SE DECISION MADE: 22-DEC-11 MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1 ACARE TECHNOLOGY CO., LTD. 510(k) NO: K111617(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 21 22815850 P.O. BOX 237-023 SE DECISION MADE: 22-DEC-11 SHANGHAI CH 200237 510(k) STATEMENT DEVICE: SYNAPSE MPR FUSION FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K113244(SPECIAL) ATTN: DEBBIE PEACOOK PHONE NO : 203 602 3774 419 WEST AVE. SE DECISION MADE: 22-DEC-11 STAMFORD CT 06902 6300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE ORTHO KINEMATICS, INC. 510(k) NO: K112109(TRADITIONAL) ATTN: JOHN J SMITH PHONE NO : 202 637 3638 555 13TH STREET NW SE DECISION MADE: 22-DEC-11 WASHINGTON DC 20005 3096 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLLAGEN TENDON SHEET ROTATION MEDICAL, INC. 510(k) NO: K112423(TRADITIONAL) ATTN: JEFF SIMS PHONE NO : 763 746 7502 15350 25TH AVENUE N SUITE 100 SE DECISION MADE: 22-DEC-11 PLYMOUTH MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANUJET III VBM MEDIZINTECHNIK GMBH 510(k) NO: K112783(TRADITIONAL) ATTN: ANKE BLOCHER PHONE NO : 49 745 4959666 1, EINSTEINSTRASSE SULZ AM NECKAR,SE DECISION MADE: 22-DEC-11 BADEN-WURTTEMBERG GM 72172 510(k) STATEMENT DEVICE: IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS PHADIA US INC. 510(k) NO: K111919(TRADITIONAL) ATTN: MARTIN MANN PHONE NO : 269 492 1957 4169 COMMERCIAL AVE. SE DECISION MADE: 22-DEC-11 PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUIDEL MOLECULAR INFLUENZA A + B ASSAY QUIDEL CORP. 510(k) NO: K112172(TRADITIONAL) ATTN: RONALD LOLLAR PHONE NO : 858 552 1100 10165 MCKELLAR CT. SE DECISION MADE: 22-DEC-11 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLS PEEK FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K113591(TRADITIONAL) ATTN: PATRICIA DONNARD PHONE NO : 332 985 56895 ZI DE KERNEVEZ-6 RUE NOBEL SE DECISION MADE: 22-DEC-11 QUIMPER FR 29000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER TOMOTHERAPY INCORPORATED 510(k) NO: K112776(TRADITIONAL) ATTN: GREG BANGE PHONE NO : 608 830 3605 1240 DEMING WAY SE DECISION MADE: 22-DEC-11 MADISON WI 53717 1954 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G MEDOS INTERNATIONAL SARL 510(k) NO: K112907(TRADITIONAL) ATTN: ROBIN DINARDO PHONE NO : 508 828 3218 325 PARAMOUNT DRIVE SE DECISION MADE: 22-DEC-11 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROCHE ACETAMINOPHEN ASSAY ROCHE DIAGNOSTICS 510(k) NO: K110726(TRADITIONAL) ATTN: ANGELO PEREIRA PHONE NO : 317 521 3544 9115 HAGUE ROAD SE DECISION MADE: 23-DEC-11 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K110717(TRADITIONAL) ATTN: JILLIAN M REED PHONE NO : 203 459 0659 25 WALNUT STREET SE DECISION MADE: 23-DEC-11 MONROE CT 06468 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TINA-QUANT HBA1C GEN.2 ROCHE DIAGNOSTICS 510(k) NO: K110313(TRADITIONAL) ATTN: SUSAN HOLLANDBECK PHONE NO : 317 521 3380 9115 HAGUE ROAD SE DECISION MADE: 23-DEC-11 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023) TOTOKU ELECTRIC CO., LTD. 510(k) NO: K113443(TRADITIONAL) ATTN: TSUKASA TASHIRO PHONE NO : 812 582 46611 300 OYA SE DECISION MADE: 23-DEC-11 UEDA JA 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMERIX COMPOSITE SURGICAL MESH BIOMERIX CORPORATION 510(k) NO: K112499(TRADITIONAL) ATTN: CHRISTINA L KICHULA PHONE NO : 510 933 1222 47757 FREMONT BLVD SE DECISION MADE: 23-DEC-11 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AU5800(R) CHEMISTRY ANALYZER BECKMAN COULTER, INC. 510(k) NO: K112412(TRADITIONAL) ATTN: DAVID G DAVIS PHONE NO : 469 236 8180 250 S. KRAEMER BOULEVARD MAIL STOPSE DECISION MADE: 23-DEC-11 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASY TOUCH MHC MEDICAL PRODUCTS, LLC 510(k) NO: K112789(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO CT. SE DECISION MADE: 23-DEC-11 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MED-RX EXTENSION SET WITH T-CONNECTOR BENLAN INC 510(k) NO: K112799(TRADITIONAL) ATTN: CHERYL BROWN PHONE NO : 905 829 5004 2760 BRIGHTON RD SE DECISION MADE: 23-DEC-11 OAKVILLE CA L6H 5T4 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL INVIVO CORPORATION 510(k) NO: K111673(TRADITIONAL) ATTN: ELIZABETH WHEELER PHONE NO : 352 336 0010 3545 S.W. 47TH AVE. SE DECISION MADE: 23-DEC-11 GAINESVILLE FL 32608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DR. GREENSBURG'S HYBRID ALWAYS MORE MARKETING INC 510(k) NO: K111680(ABBREVIATED) ATTN: JONATHAN GREENBURG PHONE NO : 818 414 4817 4535 W. SAHARA AVE., STE 200 SE DECISION MADE: 23-DEC-11 LAS VEGAS NV 89102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER RESORBABLE FIXATION SYSTEM STRYKER 510(k) NO: K113109(SPECIAL) ATTN: MANISH PATEL PHONE NO : 269 389 4271 750 TRADE CENTER WAY STE 200 SE DECISION MADE: 23-DEC-11 PORAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMERIX ASSURE BIOMERIX CORPORATION 510(k) NO: K112567(TRADITIONAL) ATTN: CHRISTINA L KICHULA PHONE NO : 510 933 1222 47757 FREMONT BLVD SE DECISION MADE: 23-DEC-11 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. 510(k) NO: K112901(SPECIAL) ATTN: CYNTHIA HUNG PHONE NO : 886 366 86868 No.8, R&D Rd. III, Hsinchu ScienceSE DECISION MADE: 23-DEC-11 HSINCHU CITY TW 30077 510(k) STATEMENT DEVICE: GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT BIONOSTICS, INC. 510(k) NO: K112352(TRADITIONAL) ATTN: RANDY BYRD PHONE NO : 978 772 7070 7 JACKSON RD. SE DECISION MADE: 23-DEC-11 DEVENS MA 01434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZAVATION IBF SYSTEMS ZAVATION LLC 510(k) NO: K112664(TRADITIONAL) ATTN: JOHN WALKER PHONE NO : 601 919 1119 501 AVALON WAY SE DECISION MADE: 23-DEC-11 BRANDON MS 39047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS THYROGLOBULIN ANITBODY BECKMAN COULTER, INC. 510(k) NO: K112933(SPECIAL) ATTN: GERALDINE L BAGLIEN PHONE NO : 952 368 7645 1000 LAKE HAZELTINE DR. SE DECISION MADE: 27-DEC-11 CHASKA MN 55318 1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO GEISTLICH PHARMA AG 510(k) NO: K112575(TRADITIONAL) ATTN: DANIEL A KRACOV PHONE NO : 202 942 5120 555 TWELFTH STREET, NW SE DECISION MADE: 27-DEC-11 WASHINGTON DC 20004 1206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROCEDURE REHEARSAL STUDIO(TM) SIMBIONIX LTD. 510(k) NO: K112387(SPECIAL) ATTN: SHOSHANA FRIEDMAN PHONE NO : 704 899 0092 1914 J N PEASE PL. SE DECISION MADE: 27-DEC-11 CHARLOTTE NC 28262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOWRIST ONE VESSEL SEALER INTUITIVE SURGICAL, INC. 510(k) NO: K110639(TRADITIONAL) ATTN: BRANDON HANSEN PHONE NO : 408 523 2100 1266 KIFER ROAD SE DECISION MADE: 28-DEC-11 SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERAMIR CROWN & BRIDGE DOXA DENTAL AB 510(k) NO: K113040(ABBREVIATED) ATTN: MARGARETH JORVID PHONE NO : 46 70 5192640 AXEL JOHANSSONS, GATA 4-6 SE DECISION MADE: 28-DEC-11 UPPSALA SW SE-754 51 510(k) STATEMENT DEVICE: AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION NATUS MEDICAL INCORPORATED 510(k) NO: K111618(TRADITIONAL) ATTN: CHARLES L MORIN PHONE NO : 415 957 0101 388 MARKET STREET SUITE 1460 SE DECISION MADE: 28-DEC-11 SAN FRANCISCO CA 94111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS STRAUMANN USA 510(k) NO: K113283(SPECIAL) ATTN: ELAINE ALAN PHONE NO : 978 747 2513 60 MINUTETEMAN ROAD SE DECISION MADE: 28-DEC-11 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEASPINE MONOPOLAR PROBE SYSYEM SEASPINE, INC. 510(k) NO: K111671(TRADITIONAL) ATTN: DAN MILLER PHONE NO : 760 727 8399 2302 LA MIRADA DR. SE DECISION MADE: 28-DEC-11 VISTA CA 92081 7862 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM BOSTON SCIENTIFIC CORPORATION 510(k) NO: K112543(TRADITIONAL) ATTN: THOMAS HIRTE PHONE NO : 508 683 4454 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 29-DEC-11 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA RAYENCE CO., LTD 510(k) NO: K113630(SPECIAL) ATTN: DAVE KIM PHONE NO : 713 467 2607 12946 KIMBERLEY LN SE DECISION MADE: 29-DEC-11 HOUSTON TX 77079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM FLEXIBLE STENTING SOLUTIONS, INC. 510(k) NO: K112522(TRADITIONAL) ATTN: JOSEPH C GRIFFIN III PHONE NO : 732 578 0060 23 CHRISTOPHER WAY SUITE 103 SE DECISION MADE: 30-DEC-11 EATONTOWN NJ 07724 510(k) STATEMENT DEVICE: HANAROSTENT BILIARY (NNN) M.I. TECH CO., LTD. 510(k) NO: K111149(TRADITIONAL) ATTN: PAUL SUMNER PHONE NO : 770 449 7529 1733 CANTON LANE SE DECISION MADE: 30-DEC-11 MARIETTA GA 30062 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 295 TOTAL WITH SUMMARIES 273 TOTAL WITH STATEMENTS 22
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