Medical Devices
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April 2012 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD April 2012 DEVICE: HYBRID GRAFT COOK BIOTECH, INC. 510(k) NO: K111695(TRADITIONAL) ATTN: MARY A FADERAN, PHD, RAC PHONE NO : 765 497 3355 1425 INNOVATION PLACE SE DECISION MADE: 02-APR-12 WEST LAFAYETTE IN 47906 1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL ) SMALL BONE INNOVATIONS INC. 510(k) NO: K112982(TRADITIONAL) ATTN: JOHN MINIER PHONE NO : 215 428 1791 1380 SOUTH PENNSYLVANIA AVENUE SE DECISION MADE: 02-APR-12 MORRISVILLE PA 19067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE MATERIALISE N.V. 510(k) NO: K113829(TRADITIONAL) ATTN: ALEXANDRA RAZZHIVINA PHONE NO : 321 639 6280 TECHNOLOGIELAAN 15 SE DECISION MADE: 02-APR-12 LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A BAER WITH ABAER I/O FUNCTION NATUS MEDICAL INCORPORATED 510(k) NO: K112247(TRADITIONAL) ATTN: CHARLES L MORIN PHONE NO : 415 957 0101 388 MARKET STREET SUITE 1460 SE DECISION MADE: 02-APR-12 SAN FRANCISCO CA 94111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR RICH MOUNTAIN MEDICAL PRODUCTS, IN510(k) NO: K120190(ABBREVIATED) ATTN: ELIZABETH DENG PHONE NO : 909 465 9188 5748 EAGLEWOOD PLACE SE DECISION MADE: 02-APR-12 RANCHO CUCAMONGA CA 91739 510(k) STATEMENT DEVICE: XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES XIAN FRIENDSHIP MEDICAL ELECTRONIC510(k) NO: K112426(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 JIANXIANG YUAN #209 BEI SI HU ZHONSE DECISION MADE: 02-APR-12 HAIDIAN DIS., BEIJING CH 100083510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEAR + BRILLIANT LASER SYSTEM SOLTA MEDICAL, INC. 510(k) NO: K120433(SPECIAL) ATTN: KRISTINE FOSS PHONE NO : 510 780 4657 25881 Industrial Blvd SE DECISION MADE: 02-APR-12 HAYWARD CA 94545 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K120802(SPECIAL) ATTN: SARAH HOLTGREWE PHONE NO : 901 867 4476 5677 AIRLINE RD. SE DECISION MADE: 02-APR-12 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIGER SPINE SYSTEM CORELINK LLC 510(k) NO: K120696(SPECIAL) ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD SE DECISION MADE: 02-APR-12 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATHASSIT LIGHT SEEKER ENTELLUS MEDICAL, INC. 510(k) NO: K120735(SPECIAL) ATTN: GARRETT P AHLBORG PHONE NO : 763 463 7074 6705 WEDGWOOD COURT NORTH SE DECISION MADE: 02-APR-12 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PENUMBRA COIL SYSTEM/PENUMBRA COIL 400 PENUMBRA, INC. 510(k) NO: K120330(TRADITIONAL) ATTN: EMILLY T NURTHEN PHONE NO : 510 748 3314 1351 Harbor Bay Parkway SE DECISION MADE: 02-APR-12 Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAGEWRITER TC 20, 30, 50, 70 PHILIPS MEDICAL SYSTEMS 510(k) NO: K113144(TRADITIONAL) ATTN: PAUL SCHRADER PHONE NO : 978 659 2404 3000 MINUTEMAN RD. SE DECISION MADE: 03-APR-12 ANDOVER MA 01810 1099 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EPICARE YAG LIGHT AGE, INC. 510(k) NO: K113115(TRADITIONAL) ATTN: ELIZABETH REDDINGTON PHONE NO : 732 563 0600 500 APGAR DRIVE SE DECISION MADE: 03-APR-12 SOMERSET NJ 08873 1150 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES PLAXTRON INDUSTRIAL (M) SDN. BHD. 510(k) NO: K120065(TRADITIONAL) ATTN: MING-YIE JAN PHONE NO : 886 731 19989 NO. 15-2, LANE 26, MINCYUAN 1ST RDSE DECISION MADE: 03-APR-12 KAOHSIUNG CITY TW 802 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM GUNNELL, INC. 510(k) NO: K111636(TRADITIONAL) ATTN: ANDREW EVANCHO PHONE NO : 800 551 0055 8440 STATE P.O. BOX 308 SE DECISION MADE: 03-APR-12 MILLINGTON MI 48746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RTVUE XR OCT OPTOVUE, INC. 510(k) NO: K120238(SPECIAL) ATTN: JOHN J TALARICO PHONE NO : 510 623 8868 45531 Northport Loop W SE DECISION MADE: 03-APR-12 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVAIRA (ENFILCON A) CONTACT LENS COOPERVISION, INC. 510(k) NO: K113759(SPECIAL) ATTN: KARIN GASTINEAU PHONE NO : 925 321 3732 6150 STONERIDGE MALL ROAD SUITE 37SE DECISION MADE: 03-APR-12 PLEASANTON CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAPHYLOCOCCUS QUICKFISH BC ADVANDX, INC. 510(k) NO: K113371(TRADITIONAL) ATTN: BENJAMIN S CRYSTAL PHONE NO : 781 376 0009 400 TRADECENTER SUITE 6990 SE DECISION MADE: 03-APR-12 WOBURN MA 01801 510(k) STATEMENT DEVICE: SECURIS SPINAL FIXATION CUMTOM SPINE 510(k) NO: K113361(TRADITIONAL) ATTN: DAVID BRUMFIELD PHONE NO : 973 265 5043 1140 PARSIPPANY BLVD. SUITE 201 SE DECISION MADE: 03-APR-12 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED FEMORAL COMPRESSION DEVICE STERILMED, INC. 510(k) NO: K120204(TRADITIONAL) ATTN: JASON SKRAMSTED PHONE NO : 763 488 3483 11140 73RD AVE. NORTH SE DECISION MADE: 03-APR-12 MAPLE GROVE MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLINE STOPCOCK AND MANIFOLD MEDLINE INDUSTRIES, INC. 510(k) NO: K120069(TRADITIONAL) ATTN: MATT CLAUSEN PHONE NO : 847 643 4785 ONE MEDLINE PLACE SE DECISION MADE: 03-APR-12 MUNDELEIN IL 60060 510(k) STATEMENT DEVICE: HAMILTON-T1 HAMILTON MEDICAL AG 510(k) NO: K120670(SPECIAL) ATTN: RALPH AGUILA PHONE NO : 418 166 06845 VIA CRUSCH 8 SE DECISION MADE: 03-APR-12 BONADUZ SZ CH-7402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENCORE 26 ADVANTAGE KIT BOSTON SCIENTIFIC CORP. 510(k) NO: K120694(SPECIAL) ATTN: ADRIENNE HOTCHKISS PHONE NO : 763 255 0334 ONE SCIMED PLACE SE DECISION MADE: 03-APR-12 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038 JETPREP, LTD. 510(k) NO: K111274(TRADITIONAL) ATTN: JOHN SMITH PHONE NO : 202 637 3638 COLUMBIA SQUARE 555 13TH STREET, NSE DECISION MADE: 04-APR-12 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM TECHNOLOGY DELIVERY SYSTEMS, INC. 510(k) NO: K111480(TRADITIONAL) ATTN: JAMES HARVEY KNAUSS PHONE NO : 832 675 9281 1516 THALIA STREET SE DECISION MADE: 04-APR-12 NEW ORLEANS LA 70130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT FOCUS DIAGNOSTICS, INC. 510(k) NO: K113433(TRADITIONAL) ATTN: SHARON YOUNG PHONE NO : 562 240 6680 11331 Valley View Street SE DECISION MADE: 04-APR-12 CYPRESS CA 90630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM CODMAN & SHURTLEFF, INC. 510(k) NO: K120686(SPECIAL) ATTN: KIM FONDA PHONE NO : 409 433 1420 325 PARAMOUNT DR. SE DECISION MADE: 04-APR-12 RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVEREST SPINAL SYSTEM K2M, INC. 510(k) NO: K120656(SPECIAL) ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DRIVE SE SE DECISION MADE: 04-APR-12 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER COVIDIEN 510(k) NO: K120674(SPECIAL) ATTN: WING NG PHONE NO : 508 261 6596 15 HAMPSHIRE STREET SE DECISION MADE: 04-APR-12 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT SMITH & NEPHEW, INC. 510(k) NO: K120667(SPECIAL) ATTN: DAVID HENLEY PHONE NO : 901 399 6487 1450 BROOKS RD. SE DECISION MADE: 04-APR-12 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE ASI MEDICAL, INC. 510(k) NO: K110481(TRADITIONAL) ATTN: JOHN MCPEEK PHONE NO : 303 766 3646 14550 E EASTER AVE. SUITE 700 SE DECISION MADE: 05-APR-12 CENTENNIAL CO 80112 510(k) STATEMENT DEVICE: SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT HANDPIECE HEADQUARTERS INC. - HPR 510(k) NO: K113674(TRADITIONAL) ATTN: TINA STEFFANIE-OAK PHONE NO : 717 335 7230 620 S. PLACENTIA AVE SE DECISION MADE: 05-APR-12 PLACENTIA CA 92870 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR SORIN GROUP ITALIA S.R.L. 510(k) NO: K113626(TRADITIONAL) ATTN: BARRY SALL PHONE NO : 781 434 4742 195 WEST STREET SE DECISION MADE: 05-APR-12 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUCAL PULPDENT CORPORATION 510(k) NO: K120003(TRADITIONAL) ATTN: KENNETH J BERK PHONE NO : 617 926 6666 80 Oakland St SE DECISION MADE: 05-APR-12 WATERTOWN MA 02472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STELLAR 150 RESMED GERMANY INC. 510(k) NO: K113640(TRADITIONAL) ATTN: DAVID D'CRUZ PHONE NO : 858 836 5984 9001 SPECTRUMA CENTER BOULEVARD SE DECISION MADE: 05-APR-12 SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRINDCARE MEASURE MEDOTECH A/S 510(k) NO: K113677(TRADITIONAL) ATTN: CALLEY HERZOG PHONE NO : 720 883 3633 13417 QUIVAS ST SE DECISION MADE: 05-APR-12 WESTMINSTER CO 80234 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 2GC HIP/KNEE MODULAR SPACER MANDELL HORWITZ CONSULTANTS LLC 510(k) NO: K112470(TRADITIONAL) ATTN: DIANE M HORWITZ PHONE NO : 703 307 2921 2995 STEVEN MARTIN DR SE DECISION MADE: 05-APR-12 FAIRFAX VA 22031 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STEAM DOT BLU PROCESS INDICATOR PROPPER MFG. CO., INC. 510(k) NO: K111453(ABBREVIATED) ATTN: ANDREW SHARAVARA PHONE NO : 718 392 6650 36-04 SKILLMAN AVE. SE DECISION MADE: 05-APR-12 LONG ISLAND CITY NY 11101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANTAGE LASER SYSTEM LUTRONIC CORPORATION 510(k) NO: K113502(TRADITIONAL) ATTN: MAUREEN O'CONNELL PHONE NO : 978 207 1245 5 TIMBER LANE SE DECISION MADE: 05-APR-12 NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CMI IMPLANT IS SYSTEM NEOBIOTECH CO., LTD. 510(k) NO: K113554(SPECIAL) ATTN: APRIL LEE PHONE NO : 714 525 0114 325 N PUENTE ST. UNIT B SE DECISION MADE: 05-APR-12 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EAGLE EYE PLATINUM ST CATHETER VOLCANO CORPORATION 510(k) NO: K120697(SPECIAL) ATTN: MARILYN POURAZAR PHONE NO : 858 720 4116 3661 Valley Centre Drive Suite 200SE DECISION MADE: 05-APR-12 San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM CHOICE SPINE, LP 510(k) NO: K120570(TRADITIONAL) ATTN: MARK BEKKALA PHONE NO : 865 246 3333 400 Erin Dr SE DECISION MADE: 05-APR-12 KNOXVILLE TN 37919 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES COLOPLAST A/S 510(k) NO: K120828(SPECIAL) ATTN: REBEKA STOLTMAN PHONE NO : 612 302 4997 1601 WEST RIVER ROAD NORTH SE DECISION MADE: 05-APR-12 MINNEAPOLIS MN 55411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERVICAL PLATE EISERTECH, LLC 510(k) NO: K113170(TRADITIONAL) ATTN: LUKAS EISERMANN PHONE NO : 888 262 2817 2555 FRONT STREET SE DECISION MADE: 06-APR-12 SAN DIEGO CA 92103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM HOLOGIC, INC. 510(k) NO: K120388(SPECIAL) ATTN: EILEEN M BOYLE PHONE NO : 781 999 7781 35 CROSBY DR. SE DECISION MADE: 06-APR-12 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL APEX BIOTECHNOLOGY CORP. 510(k) NO: K120448(SPECIAL) ATTN: LISA LIU PHONE NO : 011 886 35641952 NO. 7, LI-HSIN ROAD V, HSINCHU SCISE DECISION MADE: 06-APR-12 HSINCHU TW 30078 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWER WHEELCHAIR SUZHOU KD MEDICAL APPLIANCE CO., L510(k) NO: K113463(TRADITIONAL) ATTN: JUNNATA CHANG PHONE NO : 886 422 465396 16F-2(16A), NO. 462 SEC. 2 CHONGDESE DECISION MADE: 06-APR-12 TAICHUNG TW 406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAYSTATION RAYSEARCH LABORATORIES AB 510(k) NO: K120387(TRADITIONAL) ATTN: DAVID HEDFORS PHONE NO : 46 722 366110 SVEAVAGEN 25 SE DECISION MADE: 06-APR-12 STOCKHOLM SW 111 34 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NANOFUSE DBM NANOTHERAPEUTICS 510(k) NO: K120279(TRADITIONAL) ATTN: GREGG RITTER PHONE NO : 386 462 9663 13859 PROGRESS BLVD SUITE 300 SE DECISION MADE: 06-APR-12 ALACHUA FL 32615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNAPSE 3D BASE TOOLS FUJIFILM MEDICAL SYSTEMS USA, INC.510(k) NO: K120361(TRADITIONAL) ATTN: DEBBIE PEACOCK PHONE NO : 203 602 3774 419 WEST AVENUE SE DECISION MADE: 06-APR-12 STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX BIO-SUTURE ARTHREX, INC. 510(k) NO: K112899(TRADITIONAL) ATTN: SALLY FOUST PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 06-APR-12 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTI-MODALITY IMAGE FUSION IGT LLC DBA EIGEN 510(k) NO: K120187(TRADITIONAL) ATTN: WILLIAM MANDEL PHONE NO : 530 274 1240 13366 GRASS VALLEY AVENUE SE DECISION MADE: 06-APR-12 GRASS VALLEY CA 95945 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ETHEREA REGULATORY INSIGHT, INC. 510(k) NO: K112505(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720 962 5412 5401 S.COTTONWOOD COURT SE DECISION MADE: 06-APR-12 GREENWOOD VILLAGE CO 80121 510(k) STATEMENT DEVICE: SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K120095(TRADITIONAL) ATTN: SUSAN KAGAN PHONE NO : 508 880 8097 325 PARAMOUNT DR. SE DECISION MADE: 06-APR-12 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUILION PRIME TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K120710(SPECIAL) ATTN: PAUL BIGGINS PHONE NO : 714 669 7808 2441 MICHELLE DRIVE SE DECISION MADE: 06-APR-12 TUSTIN CA 92781 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EOS EOS IMAGING 510(k) NO: K120721(SPECIAL) ATTN: JOHN J SMITH PHONE NO : 202 637 3638 555 THIRTEENTH STREET, NW SE DECISION MADE: 06-APR-12 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OEC 9900 ELITE GE HEALTHCARE SURGERY GE OEC MEDIC510(k) NO: K120613(SPECIAL) ATTN: GERALD BUSS PHONE NO : 801 517 6591 384 WRIGHT BROTHERS DRIVE SE DECISION MADE: 06-APR-12 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGE1 GI CCU MODEL 22203020-114 KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K111997(TRADITIONAL) ATTN: WINKIE WONG PHONE NO : 424 218 8379 2151 E. GRAND AVE. SE DECISION MADE: 06-APR-12 EL SEGUNDO CA 90245 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE DOME GX4MP COLOR NONITOR NDS SURGICAL IMAGING 510(k) NO: K120709(SPECIAL) ATTN: JIM LENG PHONE NO : 408 776 0085 5750 HELLYER AVENUE SE DECISION MADE: 06-APR-12 SAN JOSE CA 95138 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEROSYNC FOR AERODR SYSTEM KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K120477(TRADITIONAL) ATTN: RESSELL MUNVES PHONE NO : 212 497 8208 140 EAST 45TH ST., 25TH FLOOR TWO SE DECISION MADE: 09-APR-12 NEW YORK NY 10017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIXEL APP GAUSS SURGICAL, INC. 510(k) NO: K120473(TRADITIONAL) ATTN: PEGGY MCLAUGHLIN PHONE NO : 650 520 7284 22700 ALCALDE RD SE DECISION MADE: 09-APR-12 SUNNYVALE CA 95014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPSTONE CONTROL SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K120368(TRADITIONAL) ATTN: JULIE BASSETT PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 09-APR-12 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONIXGPS VASCULAR ACCESS NEEDLE KIT ULTRASONIX MEDICAL CORPATION 510(k) NO: K120349(TRADITIONAL) ATTN: CHAS YU PHONE NO : 604 279 8550 130-4311 VIKING WAY SE DECISION MADE: 09-APR-12 RICHOND, BC CA V6V 2K9 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: WEIGHT AND BODY FAT SCALE SHINE BS0105 SHINE OVERSEAS MARKETING LIMITED 510(k) NO: K112149(TRADITIONAL) ATTN: CHARLIE MACK PHONE NO : 931 625 4938 77325 JOYCE WAY SE DECISION MADE: 09-APR-12 ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT ASCENSION ORTHOPEDIC 510(k) NO: K112481(TRADITIONAL) ATTN: BRADLEY W STRASSER PHONE NO : 512 836 5001 8700 CAMERON RD., STE. 100 SE DECISION MADE: 09-APR-12 Austin TX 78754 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS ACON LABORATORIES, INC. 510(k) NO: K112653(TRADITIONAL) ATTN: QIYI XIE PHONE NO : 858 875 8011 10125 MESA RIM RD. SE DECISION MADE: 09-APR-12 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILE LUBRICATING JELLY JIANERKANG MEDICAL DRESSING COMPAN510(k) NO: K112110(TRADITIONAL) ATTN: JORDON CHU PHONE NO : 008 651 982444628 ZHIXI TOWN SE DECISION MADE: 10-APR-12 JINTAN CITY, JIANGSU CH 213251 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET SOLANA SURGICAL LLC 510(k) NO: K120390(TRADITIONAL) ATTN: LOUISE ROCHT PHONE NO : 901 818 1860 6363 POPLAR AVE SUITE 434 SE DECISION MADE: 10-APR-12 MEMPHIS TN 38119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINI MAXLOCK EXTREME PLATING SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K120157(SPECIAL) ATTN: DEREK LEWIS PHONE NO : 330 869 9562 1065 Medina Rd. SUITE 500 SE DECISION MADE: 10-APR-12 Medina OH 44256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEFLEX NUXEN S.R.L. 510(k) NO: K113608(TRADITIONAL) ATTN: HERNAN ILARI PHONE NO : 541 146 446966 9741 JUAN B JUSTO SE DECISION MADE: 10-APR-12 BUENOS AIRES AR C1408ALB 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUILION ONE TOSHIBA MEDICAL SYSTEMS COPORATION510(k) NO: K113466(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714 669 7808 2441 MICHELLE DR SE DECISION MADE: 10-APR-12 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUILION CXL TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K112989(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714 669 7808 2441 MICHELLE DR. SE DECISION MADE: 10-APR-12 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEDCAT CURVEBEAM, LLC 510(k) NO: K113548(TRADITIONAL) ATTN: DAVID W COWAN PHONE NO : 267 483 8081 175 TITUS AVE SUITE 300 SE DECISION MADE: 10-APR-12 WARRINGTON PA 18976 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT WELCH ALLYN, INC. 510(k) NO: K120774(SPECIAL) ATTN: KEVIN CROSSEN PHONE NO : 315 685 2609 4341 STATE ST. RD. PO BOX 220 SE DECISION MADE: 10-APR-12 SKANEATELES FALLS NY 13153 0220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FINESSE PERSONAL INSULIN DELIVERY PATCH CALIBRA MEDICAL, INC. 510(k) NO: K111924(TRADITIONAL) ATTN: RICHARD J MEADER PHONE NO : 650 298 4740 220 SAGINAW DRIVE SE DECISION MADE: 10-APR-12 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORATECT ORAL FLUID DRUG SCREEN DEVICES BRANAN MEDICAL CORPORATION 510(k) NO: K103227(TRADITIONAL) ATTN: HUIYING WANG PHONE NO : 949 598 7166 140 TECHNOLOGY DRIVE SUITE 400 SE DECISION MADE: 11-APR-12 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK... RX DEVICES LLC 510(k) NO: K112073(TRADITIONAL) ATTN: CHARLES HOKANSON PHONE NO : 610 715 3263 19200 ASHVILLE HWY SE DECISION MADE: 11-APR-12 LANDRUM SC 29356 9021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BORRELIA BURGDORFERI IGG BLOT TEST GOLD STANDARD DIAGNOSTICS 510(k) NO: K113847(TRADITIONAL) ATTN: NAPOLEON MONCE PHONE NO : 530 759 8000 2851 SPAFFORD SE DECISION MADE: 11-APR-12 Davis CA 95618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KONAN SPECULAR MICROSCOPE XIV KONAN MEDICAL, INC. 510(k) NO: K120264(SPECIAL) ATTN: DAVID S FERNQUIST PHONE NO : 949 466 7137 2976 CALLE GAUCHO SE DECISION MADE: 11-APR-12 SAN CLEMENTE CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TITAN MODULAR TOTAL SHOULDER SYSTEM ASCENSION ORTHOPEDIC 510(k) NO: K112438(SPECIAL) ATTN: SUSAN WALTON PHONE NO : 512 836 5001 8700 CAMERON RD., STE. 100 SE DECISION MADE: 11-APR-12 Austin TX 78754 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEURO CHECK DEVICE WITH IO-FLEX WIRE BAXANO, INC. 510(k) NO: K113533(SPECIAL) ATTN: EDWARD SINCLAIR PHONE NO : 408 514 2200 655 River Oaks Pkwy SE DECISION MADE: 11-APR-12 San Jose CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM RAUMEDIC AG 510(k) NO: K120252(TRADITIONAL) ATTN: REINER THIEM PHONE NO : 499 252 3590 HERRMANN-STAUDINGER-STR. 2 SE DECISION MADE: 11-APR-12 HELMBRECHTS GM D 95233 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR STARBOARD MEDICAL, LLC 510(k) NO: K111050(TRADITIONAL) ATTN: ANTHONY BERAN PHONE NO : 714 283 3099 22845 SAVI RANCH PKWY SUITE H SE DECISION MADE: 12-APR-12 Yorba Linda CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE PARKELL, INC. 510(k) NO: K113839(TRADITIONAL) ATTN: DANIEL R SCHECHTER PHONE NO : 631 249 1134 300 EXECUTIVE DR. SE DECISION MADE: 12-APR-12 EDGEWOOD NY 11717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K113768(SPECIAL) ATTN: MEIRU LI PHONE NO : 886 266 258188 6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 12-APR-12 NEW TAIPEI CITY TW 248 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BILI-THERAPY PAD TYPE ATOM MEDICAL CORPORATION 510(k) NO: K111547(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 12-APR-12 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILE INSULIN PEN NEEDLE SHINA CORP. 510(k) NO: K113186(TRADITIONAL) ATTN: JISEOP JEONG PHONE NO : 82 41 8538571 691-1, BOHEUNG-RI USEONG-MYEON, GOSE DECISION MADE: 12-APR-12 CHUNGCHENGNAM-DO KS 314864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NATURALASE CO2 LASER SYSTEM FOCUS MEDICAL, LLC. 510(k) NO: K110333(TRADITIONAL) ATTN: JOHN LEE PHONE NO : 203 730 8885 23 FRANCIS J. CLARKE CIRCLE SE DECISION MADE: 12-APR-12 BETHEL CT 06801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE AMERICAN I.V. PRODUCTS, INC. 510(k) NO: K120209(TRADITIONAL) ATTN: MAJDI SHOMALI PHONE NO : 800 990 2911 7485 SHIPLEY AVE. SE DECISION MADE: 12-APR-12 HARMANS MD 21077 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT GALT MEDICAL 510(k) NO: K112398(SPECIAL) ATTN: BETSY CORTELLONI PHONE NO : 770 831 4294 5203 BRISTOL INDUSTRIAL WAY SE DECISION MADE: 12-APR-12 BUFORD GA 30518 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CURAD ANTIBACTERIAL BANDAGE MEDLINE INDUSTRIES, INC. 510(k) NO: K113583(TRADITIONAL) ATTN: MATT CLAUSEN PHONE NO : 847 643 4785 ONE MEDLINE PLACE SE DECISION MADE: 12-APR-12 MUNDELEIN IL 60060 510(k) STATEMENT DEVICE: HEMCON HEMOSTATIC GEL HEMCON MEDICAL TECHNOLOGIES EUROPE510(k) NO: K112215(TRADITIONAL) ATTN: KENDRA RATHKEY PHONE NO : 503 245 0459 10575 SW CASCADE AVENUE, SUITE 130SE DECISION MADE: 12-APR-12 PORTLAND OR 97223-4363 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCEND SHOULDER SYSTEM TORNIER, INC. 510(k) NO: K120794(SPECIAL) ATTN: BRAHIM HADRI PHONE NO : 781 249 8030 7701 FRANCE AVE SOUTH SUITE 600 SE DECISION MADE: 13-APR-12 EDINA MN 55435 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTEPIL,DEPILASE YAG LASE PLUS CASTLE LASER SYSTEMS, LIMITED 510(k) NO: K112141(TRADITIONAL) ATTN: RAYMOND R BLANCHE PHONE NO : 973 539 7444 641 SSHUNPIKE RD SUITE 311 SE DECISION MADE: 13-APR-12 CHATHAM NJ 07928 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARVISION DR 7000F JPI HEALTHCARE CO., LTD 510(k) NO: K102327(TRADITIONAL) ATTN: WILLIAM LITTLE PHONE NO : 516 513 1330 170-5 Guro-3 Dong, #608 KURO-GU SE DECISION MADE: 13-APR-12 Seoul KS 152-847 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRABEAM NEEDLE APPLICATOR CARL ZEISS SURGICAL GMBH 510(k) NO: K110590(TRADITIONAL) ATTN: JUDITH A BRIMACOMBE, MA PHONE NO : 925 577 4616 5160 HACIENDA DRIVE SE DECISION MADE: 13-APR-12 DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRX-REVOLUTION MOBILE X-RAY SYSTEM CARESTREAM HEALTH, INC. 510(k) NO: K120062(TRADITIONAL) ATTN: CAROLYN WAGNER PHONE NO : 585 627 6588 1049 W Ridge Rd SE DECISION MADE: 13-APR-12 Rochester NY 14615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MECHANICAL WHEELCHAIR AIKIN HEALTHCARE CO., LTD 510(k) NO: K120032(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720 962 5412 5401 S. COTTONWOOD CT. SE DECISION MADE: 13-APR-12 GREENWOOD VILLAGE CO 80121 510(k) STATEMENT DEVICE: ALPHAPOINT IMAGING SOFTWARE RADLOGICS, INC. 510(k) NO: K120161(TRADITIONAL) ATTN: MOSHE BECKER PHONE NO : 408 966 4874 201 LA CANADA COURT SE DECISION MADE: 13-APR-12 LOS GATOS CA 95023 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CT-GUIDE NEEDLE GUIDANCE SYSTEM ACTIVIEWS LTD 510(k) NO: K120300(TRADITIONAL) ATTN: JOHN J SMITH, M.D., J.D. PHONE NO : 202 637 3638 555 THIRTEENTH STREET, NW SE DECISION MADE: 13-APR-12 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K120315(TRADITIONAL) ATTN: NADIA SOOKDEO PHONE NO : 610 448 4918 51 VALLEY STREAM PARKWAY SE DECISION MADE: 13-APR-12 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO CT DYNAMIC ANGIO SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K120331(TRADITIONAL) ATTN: RALF HOFMANN PHONE NO : 499 191 188170 HENKESTRASSE 127 SE DECISION MADE: 13-APR-12 ERLANGEN GM D-91052 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PLYMOUTH THORACOLUMBAR PLATE SYSTEM GLOBE MEDICAL, INC. 510(k) NO: K120092(SPECIAL) ATTN: SARAH M FITZGERALD PHONE NO : 610 930 1800 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 13-APR-12 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICRO I CAREFUSION GERMANY 234 GMBH 510(k) NO: K113096(TRADITIONAL) ATTN: ELMAR NIEDERMEYER PHONE NO : 499 314 972361 LEIBNIZSTRASSE 7 SE DECISION MADE: 13-APR-12 HOECHBERG, BAVARIA GM 97204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0 TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K120135(TRADITIONAL) ATTN: INGE SCHEIDT PHONE NO : 498 932 175515 EDISONSTRASSE 6 SE DECISION MADE: 13-APR-12 UNTERSCHLEISSHEIM GM D-85716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPLOX II PEDICLE SCREW SYSTEM CAPTIVA SPINE, INC 510(k) NO: K120292(SPECIAL) ATTN: RICH JANSEN PHONE NO : 612 281 5505 13540 GUILD AVE SE DECISION MADE: 13-APR-12 APPLE VALLEY MN 55124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE NVJJB SYSTEM NUVASIVE, INC. 510(k) NO: K112717(TRADITIONAL) ATTN: ELIAS KETCHUM PHONE NO : 858 320 4588 7475 LUSK BLVD SE DECISION MADE: 13-APR-12 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE ANGIOSLIDE, LTD 510(k) NO: K120805(SPECIAL) ATTN: CLAY ANSELMO PHONE NO : 303 223 4303 11925 WEST I-70 FRONTAGE RD NORTH SE DECISION MADE: 13-APR-12 CLAY ANSELMO CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXITOUCH SYSTEM TACTILE SYSTEMS TECHNOLOGY INC 510(k) NO: K120972(TRADITIONAL) ATTN: PHILLIP ROSE PHONE NO : 612 355 5100 1331 Tyler St NE Ste 200 SE DECISION MADE: 13-APR-12 MINNEAPOLIS MN 55413 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEM ZONARE MEDICAL SYSTEMS, INC. 510(k) NO: K120703(TRADITIONAL) ATTN: MARK JOB PHONE NO : 763 682 4139 420 NORTH BERNARDO AVENUE SE DECISION MADE: 13-APR-12 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DUAL HEATED INFANT VREATHING CIROUITS FISHER & PAYKEL HEALTHCARE LTD. 510(k) NO: K103767(TRADITIONAL) ATTN: ROBERT PETRY PHONE NO : 649 574 0123 15 MAURICE PAYKEL PLACE PO BOX 146SE DECISION MADE: 16-APR-12 AUCKLAND NZ 1071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER TRANSENTERIX, INC. 510(k) NO: K120403(TRADITIONAL) ATTN: TAMMY B CARREA PHONE NO : 919 765 8420 635 DAVIS DRIVE SUITE 300 SE DECISION MADE: 16-APR-12 DURHAM NC 27560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESCALATE LAMINOPLASTY SYSTEM STRYKER SPINE 510(k) NO: K113802(TRADITIONAL) ATTN: SIMONA VOIC PHONE NO : 908 522 3482 2 PEARL COURT SE DECISION MADE: 16-APR-12 ALLENDALE NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM CODMAN & SHURTLEFF, INC. 510(k) NO: K120117(TRADITIONAL) ATTN: MEGAN HERMAN PHONE NO : 508 828 3571 325 PARAMOUNT DR. SE DECISION MADE: 16-APR-12 RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OP SPINE SYSTEM ORTHOPEDIATRICS, CORP. 510(k) NO: K120291(TRADITIONAL) ATTN: MARK FOX PHONE NO : 574 268 6379 2850 FRONTIER DRIVE SE DECISION MADE: 16-APR-12 WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPERCATH Z3V TOGO MEDIKIT CO., LTD. 510(k) NO: K112290(TRADITIONAL) ATTN: FUMIAKI KANAI PHONE NO : 81 338 188577 4-1-17 HONGO SE DECISION MADE: 16-APR-12 BUNKYO-KU, TOKYO JA 113-0033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSCORP SPINAL ACCESS SYSTEM TRANSCORP, INC. 510(k) NO: K113352(TRADITIONAL) ATTN: ANDREW RODENHOUSE PHONE NO : 616 855 5375 1000 100th St. SW SUITE F SE DECISION MADE: 16-APR-12 Byron Center MI 49315 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) CARTICEPT MEDICAL INC 510(k) NO: K120830(SPECIAL) ATTN: TANYA EBERLE PHONE NO : 770 754 3814 6120 WINDWARD PARKWAY SUITE 220 SE DECISION MADE: 16-APR-12 ALPHARETTA GA 30005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIAC SORDINA S.P.A. 510(k) NO: K110840(ABBREVIATED) ATTN: BERTHOIN CLAUDE PHONE NO : 386 672 0450 110 E. GRANADA BLVD SUITE 207 SE DECISION MADE: 17-APR-12 ORMOND BEACH FL 32176 510(k) STATEMENT DEVICE: IND URINARY TRACT INFECTION (UTI) TEST STRIPS IND DIAGNOSTIC, INC. 510(k) NO: K103037(TRADITIONAL) ATTN: KAI LOU PHONE NO : 604 522 1619 1629 FOSTERS WAY SE DECISION MADE: 17-APR-12 DELTA, B.C. CA V3M 6S7 510(k) STATEMENT DEVICE: AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES PEGAVISION CORPORATION 510(k) NO: K120028(TRADITIONAL) ATTN: TONY HSU PHONE NO : 886 332 98808 2F-1 NO.5, SHING YEH ST. SHAN DINGSE DECISION MADE: 17-APR-12 TAOYUAN TW 33341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME RIVERSTONE RESOURCES SDN. BHD. 510(k) NO: K112928(TRADITIONAL) ATTN: CHONG CHU MEE PHONE NO : 603 602 83033 LOT 56, NO. 15, JALAN JASMIN 2 SE DECISION MADE: 17-APR-12 BUKIT BERUNTUNG, SELANGOR MY 48510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIOGRAPHIC X-RAY SYSTEM ORICH MEDICAL EQUIPMENT (TIANJIN C510(k) NO: K120034(TRADITIONAL) ATTN: JUN PENG PHONE NO : 305 609 4701 6840 SW 45TH LN #5 SE DECISION MADE: 17-APR-12 MIAMI FL 33155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3MENSIO WORKSTATION PIE MEDICAL IMAGING B.V. 510(k) NO: K120367(TRADITIONAL) ATTN: FLORIE DANIELS PHONE NO : 314 332 81328 BECANUSSTRAAT 13 D SE DECISION MADE: 17-APR-12 MAASTRICHT NL 6216 BX 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL HEALGEN SCIENTIFIC, LLC 510(k) NO: K111999(TRADITIONAL) ATTN: YONGQUAN WANG PHONE NO : 713 661 6267 5213 MAPLE STREET SE DECISION MADE: 17-APR-12 BELLAIRE TX 77401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES THUNDER TIGER CORP. 510(k) NO: K112305(ABBREVIATED) ATTN: JO LEE PHONE NO : 886 423 591616 NO. 7, 6TH ROAD INDUSTRY PARK SE DECISION MADE: 17-APR-12 TAICHUNG TW 40755 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOFRIC SINGLE USE URINARY CATHETER ASTRA TECH AB 510(k) NO: K113424(TRADITIONAL) ATTN: FLOYD G LARSON PHONE NO : 858 792 1235 11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 17-APR-12 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXTGEN ALTIUS OCT SYSTEM BIOMET SPINE (AKA EBI, LLC) 510(k) NO: K113593(TRADITIONAL) ATTN: VIVIAN KELLY PHONE NO : 973 299 9300 100 INTERPACE PARKWAY SE DECISION MADE: 17-APR-12 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRAOSSEOUS FIXATION SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K120165(TRADITIONAL) ATTN: DEREK LEWIS PHONE NO : 330 869 9562 1065 Medina Rd. SUITE 500 SE DECISION MADE: 17-APR-12 Medina OH 44256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TARGET DETACHABLE COIL STRYKER NEUROVASCULAR 510(k) NO: K120850(SPECIAL) ATTN: RHODA SANTOS PHONE NO : 510 413 2269 47900 BAYSIDE PARKWAY SE DECISION MADE: 17-APR-12 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002) NOVITAS MEDICAL, LLC 510(k) NO: K121001(TRADITIONAL) ATTN: MARSHAL FRYMAN PHONE NO : 727 743 5040 451 WEST LAMBERT ROAD SUITE 209 SE DECISION MADE: 17-APR-12 BREA CA 92821 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: INZONE DETACHMENT SYSTEM STRYKER 510(k) NO: K120816(SPECIAL) ATTN: MARA CHOU PHONE NO : 510 413 2595 47900 BAYSIDE PARKWAY SE DECISION MADE: 17-APR-12 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 DIAMOND DIAGNOSTICS, INC 510(k) NO: K120591(TRADITIONAL) ATTN: KATHY CRUZ PHONE NO : 508 429 0450 333 Fiske St SE DECISION MADE: 17-APR-12 Holliston MA 01746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WUNDER TEST HIEN HELEN NGUYEN 510(k) NO: K102428(TRADITIONAL) ATTN: HIEN NGUYEN PHONE NO : 408 234 1368 1810 OAKLAND RD., STE E SE DECISION MADE: 18-APR-12 SAN JOSE CA 95131 510(k) STATEMENT DEVICE: AB DENTAL DEVICES IMPLANTS AND ACCESSORIES A.B. DENTAL DEVICES, LTD. 510(k) NO: K112440(TRADITIONAL) ATTN: CHARLES HURWITZ PHONE NO : 972 392 33666 POB 367 SE DECISION MADE: 18-APR-12 RAMAT HASHARON, IS 47103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ON CALL CHOSEN LANCING DEVICE ACON LABORATORIES, INC. 510(k) NO: K113332(ABBREVIATED) ATTN: AARON FRIDAY PHONE NO : 858 875 8057 10125 Mesa Rim Road SE DECISION MADE: 18-APR-12 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TWIN PEAKS LUMBAR CAGE QUALGENIX LLC 510(k) NO: K112696(TRADITIONAL) ATTN: RICHARD DESLAURIERS PHONE NO : 203 262 9340 1 JACK'S HILL ROAD UNIT 3E SE DECISION MADE: 18-APR-12 OXFORD CT 06478 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZHENJIANG ASURE MECHANICAL WHEELCHAIR ZHENJIANG ASSURE MEDICAL EQUIPMENT510(k) NO: K112816(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. FU CHIUN STREET SE DECISION MADE: 18-APR-12 HSIN CHU CITY TW 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXUS TKO-6, LUER-ACTIVATED DEVICE NEXUS MEDICAL, LLC 510(k) NO: K113398(TRADITIONAL) ATTN: HEATHER TURNER PHONE NO : 913 451 2234 11315 STRANG LINE ROAD SE DECISION MADE: 18-APR-12 LENEXA KS 66215 510(k) STATEMENT DEVICE: SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS SYNERGEYES, INC. 510(k) NO: K113586(ABBREVIATED) ATTN: RICHARD E LIPPMAN PHONE NO : 240 683 3738 15825 SHADY GROVE ROAD SUITE 30 SE DECISION MADE: 18-APR-12 ROCKVILLE MD 20850 510(k) STATEMENT DEVICE: JAZZY ELITE 6 PRIDE MOBILITY PRODUCT CORPORRATIO510(k) NO: K113488(SPECIAL) ATTN: KIMBERLY BLAKE PHONE NO : 570 655 5574 182 SUSQUEHANNA AVE. SE DECISION MADE: 18-APR-12 EXETER PA 18643 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSAFITCUP CC TRIO-ADDITIONAL LINERS MEDACTA INTERNATIONAL 510(k) NO: K120531(SPECIAL) ATTN: ADAM GROSS PHONE NO : 805 437 7085 4725 CALLE QUETZAL, UNIT B SE DECISION MADE: 18-APR-12 CAMARILLO CA 93012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANTARAY GUIDEWIRES BRIDGEPOINT MEDICAL 510(k) NO: K120881(SPECIAL) ATTN: JILL MUNSINGER PHONE NO : 763 225 8500 13355 10TH AVE N, SUITE #110 SE DECISION MADE: 18-APR-12 PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODULAR PROXIMALLY FLUTED HIP STEM SMITH & NEPHEW, INC. 510(k) NO: K113789(ABBREVIATED) ATTN: NATALIE P WILLIAMS PHONE NO : 901 399 5161 7135 GOODLETT FARMS PARKWAY SE DECISION MADE: 19-APR-12 CORDOVA TN 38016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM L&K BIOMED CO., LTD 510(k) NO: K120063(SPECIAL) ATTN: HEE KYEONG JOO PHONE NO : 822 262 41475 #1104, ACE HIGH-END TOWER 3 CHA, 3SE DECISION MADE: 19-APR-12 GEUMCHEON-GU, SEOUL KS 153-803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULSE OXIMETER NONIN MEDICAL, INC. 510(k) NO: K112843(TRADITIONAL) ATTN: BRODIE PEDERSON PHONE NO : 763 577 3180 13700 1ST AVE. NORTH SE DECISION MADE: 19-APR-12 PLYMOUTH MN 55441 5443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIMUS HEARING INSTRUMENT TEST UNIT AUDITDATA A/S 510(k) NO: K113831(TRADITIONAL) ATTN: DAN HAUGBOL PHONE NO : 457 020 3124 BANESTROEGER 13 SE DECISION MADE: 19-APR-12 TAASTRUP DA DK-2630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. 510(k) NO: K120316(TRADITIONAL) ATTN: AMITA S SHAH PHONE NO : 781 345 9164 11 North Ave SE DECISION MADE: 19-APR-12 Burlington MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES NEOMED, INC. 510(k) NO: K120182(TRADITIONAL) ATTN: PENNY NORTHCUTT PHONE NO : 678 428 6978 717 LAKEGLEN DR. SE DECISION MADE: 19-APR-12 SUWANEE GA 30024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVAC 11 NEW RADIANT TECHNOLOGY S.P.A. 510(k) NO: K112286(TRADITIONAL) ATTN: MAUREEN O'CONNEL PHONE NO : 978 207 1245 5 TIMBER LANE SE DECISION MADE: 19-APR-12 NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRTUOSO SYSTEM FOR IHC P53 (DO-7) VENTANA MEDICAL SYSTEMS, INC. 510(k) NO: K111872(TRADITIONAL) ATTN: TROY QUANDER PHONE NO : 520 229 4184 1910 EAST INNOVATION PARK DR. SE DECISION MADE: 19-APR-12 TUCSON AZ 85755 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONICISION STERILIZATION TRAY COVIDIEN 510(k) NO: K112536(ABBREVIATED) ATTN: DAVID M HORTON PHONE NO : 303 530 6391 5920 LONGBOW DR. SE DECISION MADE: 19-APR-12 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLEA EMERGO GROUP, INC. 510(k) NO: K120196(TRADITIONAL) ATTN: KRISTI GUSMAN PHONE NO : 512 327 9997 611 WEST 5TH ST THIRD FLOOR SE DECISION MADE: 19-APR-12 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM GE VINGMED ULTRASOUND AS 510(k) NO: K120201(TRADITIONAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 W INNOVATION DR., RP-2138 SE DECISION MADE: 19-APR-12 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZONO 3000 LIFE-TECH, INC. 510(k) NO: K120234(TRADITIONAL) ATTN: SKIP RIMER PHONE NO : 281 491 6600 13235 N Promenade Blvd SE DECISION MADE: 19-APR-12 Stafford TX 77477 510(k) STATEMENT DEVICE: NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA NOBLES MEDICAL TECHNOLOGIES II, IN510(k) NO: K113494(SPECIAL) ATTN: MARIA HATEGAN PHONE NO : 714 427 0398 17080 Newhope St SE DECISION MADE: 19-APR-12 Fountain Valley CA 92708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS MICRODOSE PHILIPS DIGITAL MAMMOGRAPHY SWEDEN510(k) NO: K120255(TRADITIONAL) ATTN: GUSTAV LINS PHONE NO : 468 623 5200 Smidesvagen 5 SE DECISION MADE: 19-APR-12 Solna SW SE-171 41 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 2MP MONOCHROME LCD MONITOR, RADIFORCE GX240 EIZO NANAO CORPORATION 510(k) NO: K120407(TRADITIONAL) ATTN: HIROAKI HASHIMOTO PHONE NO : 81 762 742468 153 SHIMOKASHIWANO SE DECISION MADE: 19-APR-12 HAKUSAN JA 924-8566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESOLUTIONMD WEB CALGARY SCIENTIFIC, INC. 510(k) NO: K120076(TRADITIONAL) ATTN: KYLE PETERSON PHONE NO : 403 767 7945 SUITE 208, 1210 20TH AVENUE SE SE DECISION MADE: 19-APR-12 CALGARY, ALBERTA CA T2G 1M8 510(k) STATEMENT DEVICE: OTIS-C PLUS SCIENCE FOR BIOMATERIALS 510(k) NO: K120818(SPECIAL) ATTN: DENIS CLEMENT PHONE NO : 330 562422 101 ZI DU MONGE SE DECISION MADE: 19-APR-12 LOURDES FR F 65100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K121010(TRADITIONAL) ATTN: YANG ZHAOHUI PHONE NO : 867 558 1885640 BLDG. 9-13 BAIWANGXIN HIGH-TEC INDSE DECISION MADE: 19-APR-12 SHENZHEN CH 518108 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OPTIMA NM/CT 640 GE HEALTHCARE 510(k) NO: K121019(TRADITIONAL) ATTN: ELI WERNER PHONE NO : 972 485 63666 4 HAYOZMA STREET SE DECISION MADE: 19-APR-12 TIRAT HACARMEL IS 30200 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PRE-LOADED GOLD VISICOIL CK MARKER RADIOMED CORPORATION 510(k) NO: K120859(SPECIAL) ATTN: GORDON ROBERTS PHONE NO : 901 432 7202 3150 STAGE POST DRIVE SE DECISION MADE: 19-APR-12 Bartlett TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K120699(TRADITIONAL) ATTN: WU ZICUI PHONE NO : 867 552 6582888 MINDRAY BUILDING, KEJI 12TH RD SOUSE DECISION MADE: 19-APR-12 NANSHAN,SHENZHEN, P.R. CHINA CH510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ATLAS PTA BALLOON DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC. 510(k) NO: K120971(TRADITIONAL) ATTN: MEGAN BROWN PHONE NO : 480 379 2848 1415 WEST 3RD ST. SE DECISION MADE: 19-APR-12 TEMPE AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: WHOLEY GUIDE WIRE SYSTEM COVIDIEN LLC 510(k) NO: K120863(TRADITIONAL) ATTN: DAVID RBERTSON PHONE NO : 763 398 7000 3033 CAMPUS DRIVE SE DECISION MADE: 19-APR-12 PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: RIVAL PTA DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC. 510(k) NO: K120722(TRADITIONAL) ATTN: MARK JOB PHONE NO : 763 682 4139 1415 WEST 3RD ST. SE DECISION MADE: 19-APR-12 TEMPE AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ORBIT NATIONAL BIOMEDICAL LLC DBA QRS DI510(k) NO: K120880(SPECIAL) ATTN: MARY KAY JENSEN PHONE NO : 763 559 8492 6901 E. Fish Lake Road Suite 188 SE DECISION MADE: 19-APR-12 Maple Grove MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTAPACS/INSTARISPACS MEDDIFF TECHNOLOGIES PVT. LTD 510(k) NO: K120718(SPECIAL) ATTN: CARL ALLETTO PHONE NO : 469 684 1980 1600 MANCHESTER WAY SE DECISION MADE: 19-APR-12 CORINTH TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES DIPPED PRODUCTS (THAILAND) LTD 510(k) NO: K111464(TRADITIONAL) ATTN: L.G.S. GUNAWARDANA PHONE NO : 667 430 2100 82/2 MOO 9, TUMBON RATTAPUM AMPHURSE DECISION MADE: 19-APR-12 SONGKLA TH 90220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXCELSIOR XT-27 MICROCATHETER STRYKER NEUROVASCULAR 510(k) NO: K113778(TRADITIONAL) ATTN: YOKO Y ENRILE PHONE NO : 510 413 2619 47900 BAYSIDE PARKWAY SE DECISION MADE: 20-APR-12 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EASYCARE TX SYSTEM (CONNEXUNS) RESMED LTD. 510(k) NO: K113780(TRADITIONAL) ATTN: DAVID D'CRUZ PHONE NO : 858 836 5984 9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 20-APR-12 SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MCKESSON ANESTHESIA CARE MCKESSON TECHNOLOGIES INC. 510(k) NO: K113633(TRADITIONAL) ATTN: JANICE M HOGAN PHONE NO : 267 675 4611 1835 MARKET STREET 29TH FLOOR SE DECISION MADE: 20-APR-12 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FENESTRATED NERVE BLOCK NEEDLE IMD INC 510(k) NO: K113662(TRADITIONAL) ATTN: WALTER ZOHMANN PHONE NO : 800 824 8223 PO BOX 510 9202 KELLY DRIVE SE DECISION MADE: 20-APR-12 HUNTSVILLE UT 84317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GORE DRYSEAL SHEATH W. L. GORE & ASSOCIATES, INC. 510(k) NO: K120428(SPECIAL) ATTN: NANCY B LOWE PHONE NO : 800 437 8181 1505 N. FOURTH ST. SE DECISION MADE: 20-APR-12 FLAGSTAFF AZ 86004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLUWHITE DIAMOND DENTAL BURS MODIFIED BEAVERS DENTAL, DIV. SYBRON CANADA510(k) NO: K120037(TRADITIONAL) ATTN: WENDY GARMAN PHONE NO : 714 516 7602 1717 WEST COLLINS AVENUE SE DECISION MADE: 20-APR-12 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML NEPHRON PHARMACEUTICALS CORP. 510(k) NO: K120051(TRADITIONAL) ATTN: MARCUS JULIANO PHONE NO : 407 246 1389 4121 34TH ST. S.W. SE DECISION MADE: 20-APR-12 ORLANDO FL 32811 6475 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPID PROGRAMMER ST. JUDE MEDICAL 510(k) NO: K113611(TRADITIONAL) ATTN: TERI GILIO PHONE NO : 972 526 8275 6901 PRESTON ROAD SE DECISION MADE: 20-APR-12 PLANO TX 75024 510(k) STATEMENT DEVICE: NEO CR KNEE SYSTEM PIPELINE ORTHOPEDICS 510(k) NO: K120313(TRADITIONAL) ATTN: TERRY POWELL PHONE NO : 703 562 9800 901 KING STREET, SUITE 200 SE DECISION MADE: 20-APR-12 ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EARLOGIC OAE TESTER EARLOGIC CORPORATION 510(k) NO: K112992(TRADITIONAL) ATTN: SHIN KUK YOO PHONE NO : 714 313 7442 8 EAST BROADWAY SUITE 611 SE DECISION MADE: 20-APR-12 SALY LAKE CITY UT 84111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SALINE WOUND WASH NANOPLAS, INC. 510(k) NO: K112666(TRADITIONAL) ATTN: RYAN LYTLE PHONE NO : 847 228 6050 2140 TOUHY AVE SE DECISION MADE: 20-APR-12 ELK GROVE VILLAGE IL 60007 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K111425(TRADITIONAL) ATTN: SHERI MUSGNUNG PHONE NO : 484 896 3147 3500 CORPORATE PARKWAY P.O. BOX 61SE DECISION MADE: 20-APR-12 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALTOP DENTAL IMPLANT SYSTEM PALTOP ADVANCED DENTAL SOLUTIONS L510(k) NO: K112795(TRADITIONAL) ATTN: TAL HAMMER-TOPAZ PHONE NO : 972 462 71711 5 HASHITA STREET SE DECISION MADE: 20-APR-12 CAESAREA IS IS 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABBOTT NUTRITION ENTERAL FEEDINGS SET WITH SPIKERIGHT PLUS PROXIMAL CONNECTOR ABBOT LABORATORIES 510(k) NO: K113719(TRADITIONAL) ATTN: ELIZABETH M ZOLA PHONE NO : 614 624 3316 3300 STELZER ROAD SE DECISION MADE: 20-APR-12 COLUMBUS OH 43219 3034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3.7 MP COLOR LCD MONITOR, RADIFORCE MX270W EIZO NANAO CORPORATION 510(k) NO: K113240(TRADITIONAL) ATTN: HIROAKI HASHIMOTO PHONE NO : 817 627 42468 153 SHIMOKASHIWANO, SE DECISION MADE: 20-APR-12 HAKUSAN, ISHIKAWA JA 924-8566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES MAUNA KEA TECHNOLOGIES 510(k) NO: K120208(SPECIAL) ATTN: MICHAEL A DANIEL PHONE NO : 415 407 0223 8 SNOWBERRY COURT SE DECISION MADE: 20-APR-12 ORINDA CA 94563 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER DATASCOPE CORP., CARDIAC ASSIST DI510(k) NO: K120868(SPECIAL) ATTN: HELDER A SOUSA PHONE NO : 201 995 8710 15 LAW DR. SE DECISION MADE: 20-APR-12 FAIRFIELD NJ 07004 0011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS UNOMEDICAL A/S INFUSION DEVICES 510(k) NO: K120872(SPECIAL) ATTN: JOHN M LINDSKOG PHONE NO : 45 48 167000 AAHOLMVEJ 1-3, OSTED SE DECISION MADE: 20-APR-12 LEJRE DA DK-4320 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC PARCUS MEDICAL, LLC 510(k) NO: K120942(SPECIAL) ATTN: PAUL VAGTS PHONE NO : 920 746 2972 839 SOUTH NEENAH AVE. SE DECISION MADE: 20-APR-12 STURGEON BAY WI 54235 510(k) STATEMENT DEVICE: NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, BIONESS, INC. 510(k) NO: K120853(SPECIAL) ATTN: KIM TOMPKINS PHONE NO : 661 362 5968 25103 RYE CANYON LOOP SE DECISION MADE: 20-APR-12 VALENCIA CA 91355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLAT PANEL DETECTOR CANON, INC.-MEDICAL EQUIPMENT GROU510(k) NO: K111824(TRADITIONAL) ATTN: DIANE RUTHERFORD PHONE NO : 972 480 9554 1201 RICHARDSON DRIVE SUITE 280 SE DECISION MADE: 23-APR-12 RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE SYNERGETICS, INC 510(k) NO: K113857(TRADITIONAL) ATTN: GARY OLIVEROS PHONE NO : 636 794 5107 3845 CORPORATE CENTRE DRIVE SE DECISION MADE: 23-APR-12 O'FALLON MO 63368 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOME PREGNANCY TEST NEWSCEN COAST BIO-PHARMACEUTICAL C510(k) NO: K112315(TRADITIONAL) ATTN: CHANDRAVADAN PATEL PHONE NO : 805 581 4502 2117 CLANEY CT SE DECISION MADE: 23-APR-12 SIMI VALLEY CA 93065 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISIA MEVIS MEDICAL SOLUTIONS AG 510(k) NO: K120207(TRADITIONAL) ATTN: THOMAS E TYNES PHONE NO : 262 691 9530 N27 W24075 PAUL COURT SUITE 100 SE DECISION MADE: 23-APR-12 PEWAUKEE WI 53072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION BESTGEN BIOTECH CORP. 510(k) NO: K103230(TRADITIONAL) ATTN: STEVEN SHEN PHONE NO : 886 282 272188 7F, NO 186, JIAN-YI ROAD SE DECISION MADE: 24-APR-12 JUNG-HE, TAIPEI COUNTY TW 235 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM CARDIOSOLUTIONS 510(k) NO: K120086(TRADITIONAL) ATTN: MICHELE LUCEY PHONE NO : 781 828 4400 375 WEST ST. SE DECISION MADE: 24-APR-12 WEST BRIDGEWATER MA 02379 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM FLEXIBLE STENTING SOLUTIONS, INC. 510(k) NO: K120452(TRADITIONAL) ATTN: JOSEPH C GRIFFIN III PHONE NO : 732 578 0060 23 CHRISTOPHER WAY SUITE 103 SE DECISION MADE: 24-APR-12 EATONTOWN NJ 07724 510(k) STATEMENT DEVICE: OSTEOMED WRIST PLATING SYSTEM OSTEOMED LP 510(k) NO: K120015(TRADITIONAL) ATTN: SUZANNE CHEANG PHONE NO : 972 677 4779 3885 Arapaho Rd SE DECISION MADE: 24-APR-12 ADDISON TX 75001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL) BIOLITEC MEDICAL DEVICES, INC 510(k) NO: K120231(TRADITIONAL) ATTN: HARRY HAYES, PH.D PHONE NO : 413 250 0779 1349 MAIN ROAD SE DECISION MADE: 24-APR-12 GRANVILLE MA 01034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRAIN BIOPSY NEEDLE AD-TECH MEDICAL INSTRUMENT CORP. 510(k) NO: K112094(TRADITIONAL) ATTN: GARY J SYRING PHONE NO : 608 877 2635 800 LEVANGER LANE SE DECISION MADE: 24-APR-12 STOUGHTON WI 53589 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APLAN A.V. FISTULA NEEDLE SET APLAN WELL ENTERPRISE CO., LTD 510(k) NO: K112734(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU CHIUN STREET SE DECISION MADE: 24-APR-12 HSIN CHU CITY TW 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS HAMILTON THORNE, INC. 510(k) NO: K120055(TRADITIONAL) ATTN: DIARMAID H DOUGLAS-HAMILTON PHONE NO : 978 921 2050 100 CUMMINGS CENTER-SUITE 465E SE DECISION MADE: 24-APR-12 Beverly MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLEEPWEAVER ELAN NASAL CPAP MASK CIRCADIANCE LLC 510(k) NO: K120757(SPECIAL) ATTN: DAVID GROLL PHONE NO : 724 858 2837 1060 CORPORATE LANE SE DECISION MADE: 24-APR-12 EXPORT PA 15632 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX KIRSCHNER WIRES AND STEINMANN PINS APEX TOOLS & ORTHOPEDICS CO. 510(k) NO: K121004(SPECIAL) ATTN: HOLLACE SAAS RHODES PHONE NO : 202 552 5800 1331 H STREET NW 12TH FLOOR SE DECISION MADE: 24-APR-12 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K120645(TRADITIONAL) ATTN: RYAN BORMANN PHONE NO : 901 867 4409 5677 AIRLINE RD. SE DECISION MADE: 24-APR-12 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICCOLO HDL-CAPILLARY TEST SYSTEM ABAXIS, INC. 510(k) NO: K120662(TRADITIONAL) ATTN: DENNIS M BLEILE PHONE NO : 510 675 6515 3240 WHIPPLE RD. SE DECISION MADE: 24-APR-12 UNION CITY CA 94587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM ABAXIS, INC. 510(k) NO: K120664(TRADITIONAL) ATTN: DENNIS M BLEILE PHONE NO : 510 675 6515 3240 WHIPPLE RD. SE DECISION MADE: 24-APR-12 UNION CITY CA 94587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILAGRO INTERFERENCE SCREWS DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K120589(TRADITIONAL) ATTN: DEEP PAL PHONE NO : 508 977 3998 325 PARAMOUNT DR. SE DECISION MADE: 24-APR-12 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTROCARDIOGRAPH SHENZHEN CAREWELL ELECTRONICS CO.,510(k) NO: K113485(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 122 815850 P.O. BOX 237-023 SE DECISION MADE: 25-APR-12 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK HOWMEDICA OSTEONICS CORP DBA STRYK510(k) NO: K113760(TRADITIONAL) ATTN: VALERIE GIAMBANCO PHONE NO : 201 831 6275 325 CORPORATE DRIVE SE DECISION MADE: 25-APR-12 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS SINTEA PLASTEK, LLC 510(k) NO: K112611(SPECIAL) ATTN: DANIELLE WERNIKOWSKI PHONE NO : 305 673 6226 407 LINCOLN ROAD SUITE 10L SE DECISION MADE: 25-APR-12 MIAMI BEACH FL 33139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NASAL/EPISTAXIS PACK COGENT THERAPEUTICS, LLC 510(k) NO: K113585(TRADITIONAL) ATTN: ANNE WORDEN PHONE NO : 925 895 1200 3637 BERNAL AVENUE SE DECISION MADE: 25-APR-12 PLEASANTON CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL PROPAQ MD ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K112761(TRADITIONAL) ATTN: CHARLES W KOLIFRATH PHONE NO : 978 421 9786 269 MILL ROAD SE DECISION MADE: 25-APR-12 CHELMSFORD MA 01824 4105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. 510(k) NO: K120908(SPECIAL) ATTN: LARAINE PANGELINA PHONE NO : 714 247 8000 1311 VALENCIA AVE SE DECISION MADE: 25-APR-12 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAREFUSION NICOLET EDX CAREFUSION 209, INC. 510(k) NO: K120979(SPECIAL) ATTN: CURTIS TRUESDALE PHONE NO : 608 829 8684 1850 Deming Way SE DECISION MADE: 25-APR-12 Middleton WI 53562 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHARPS TANK REUSABLE SHARPS CONTAINER REHRIG PACIFIC COMPANY 510(k) NO: K111085(ABBREVIATED) ATTN: DAVID OLMSTEAD PHONE NO : 615 278 9292 614 HUNTERS LANE SE DECISION MADE: 25-APR-12 BRENTWOOD TN 37027 510(k) STATEMENT DEVICE: GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS GEO MEDICAL CO., LTD. 510(k) NO: K110835(TRADITIONAL) ATTN: ALBERT REGO PHONE NO : 949 770 8710 27001 LA PAZ ROAD SUITE 312 SE DECISION MADE: 26-APR-12 MISSION VIEJO CA 92691 510(k) STATEMENT DEVICE: SOLITAIRE-C CERVICAL SPACER SYSTEM EBI, LLC 510(k) NO: K113796(TRADITIONAL) ATTN: MARGARET CROWE PHONE NO : 973 299 9300 100 INTERPACE PKWY. SE DECISION MADE: 26-APR-12 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM CONVATEC INC 510(k) NO: K112342(TRADITIONAL) ATTN: KATRINA FIEDLER PHONE NO : 908 904 2541 200 HEADQUARTERS PARK DRIVE SE DECISION MADE: 26-APR-12 SKILLMAN NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IROOT 100 MINI S-DENTI CO., LTD. 510(k) NO: K112153(TRADITIONAL) ATTN: PETER CHUNG PHONE NO : 412 687 3976 300 ATWOOD SE DECISION MADE: 26-APR-12 PITTSBURGH PA 15213 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM BIOLITEC SIA (LATVIA) 510(k) NO: K120437(TRADITIONAL) ATTN: HARRY HAYES PHONE NO : 413 250 0779 1349 MAIN ROAD SE DECISION MADE: 26-APR-12 GRANVILLE MA 01034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY PULSE CERVICAL CAGE SYSTEM MEDOS INTERNATIONAL SARL 510(k) NO: K120517(TRADITIONAL) ATTN: EUGENE BANG PHONE NO : 508 977 3966 325 PARAMOUNT DR SE DECISION MADE: 26-APR-12 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AERONEB PRO AEROGEN LTD 510(k) NO: K120939(SPECIAL) ATTN: MARTHA FOLAN PHONE NO : 353 915 40400 GALWAY BUSINESS PARK, DANGAN SE DECISION MADE: 26-APR-12 GALWAY EI GALWAY 510(k) STATEMENT DEVICE: C-QUR RPM MESH ATRIUM MEDICAL CORP. 510(k) NO: K121070(SPECIAL) ATTN: JOSEPH DEPAOLO PHONE NO : 603 880 1433 5 Wentworth Dr SE DECISION MADE: 26-APR-12 HUDSON NH 03051 510(k) STATEMENT DEVICE: SECURACATH INTERRAD MEDICAL INC 510(k) NO: K120935(SPECIAL) ATTN: SEW-WAH TAY PHONE NO : 612 801 6782 8401 73RD AVE NORTH STE 63 SE DECISION MADE: 27-APR-12 MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3B RESMART CPAP AND AUTO CPAP SYSTEMS; BMC RESMART CPAP AND AUTO CPAP SYSTEMS 3B PRODUCTS, INC. 510(k) NO: K110629(TRADITIONAL) ATTN: NORMA F ESTRIN, PH.D. PHONE NO : 301 279 2899 9109 COPENHAVER DRIVE SE DECISION MADE: 27-APR-12 POTOMAC MD 20854 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES HEBEI CHANGSHENG PLASTIC PRODUCTS 510(k) NO: K113837(TRADITIONAL) ATTN: RICHARD LU PHONE NO : 861 064 796097 NO 99, HUANGJIN AVENUE, JULU COUNTSE DECISION MADE: 27-APR-12 XINGTAI, HEBEI PROVINCE CH 0552510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING CARDINAL HEALTH-MEDICAL PRODUCTS A510(k) NO: K113707(TRADITIONAL) ATTN: TATYANA BOGDAN PHONE NO : 847 887 2325 1430 WAUKEGAN RD. SE DECISION MADE: 27-APR-12 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NAMSA BIOLOGICAL INDICATOR SPORE STRIPS NORTH AMERICAN SCIENCE ASSOC., INC510(k) NO: K113221(TRADITIONAL) ATTN: JULIE WHEELER PHONE NO : 419 666 9455 6750 WALES RD. SE DECISION MADE: 27-APR-12 NORTHWOOD OH 43619 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS GE MEDICAL SYSTEMS LUNAR 510(k) NO: K113286(TRADITIONAL) ATTN: TRISHIA DWYER PHONE NO : 608 221 1551 3030 Ohmeda Dr SE DECISION MADE: 27-APR-12 MADISON WI 53718 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CSM INTERNAL-R IMPLANT SYSTEM CSM IMPLANT 510(k) NO: K120043(TRADITIONAL) ATTN: APRIL LEE PHONE NO : 714 525 0114 325 N PUENTE ST UNIT B SE DECISION MADE: 27-APR-12 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHOTIP(R) ULTRA FIDUCIAL NEEDLE WILSON-COOK MEDICAL, INC. / COOK E510(k) NO: K111895(TRADITIONAL) ATTN: MARGE WALLS-WALKER PHONE NO : 336 744 0157 4900 BETHANIA STATION ROAD SE DECISION MADE: 27-APR-12 WINSTON-SALEM NC 27105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: R3 XLPE LINERS SMITH & NEPHEW, INC. 510(k) NO: K113848(TRADITIONAL) ATTN: JOHN CONNOR PHONE NO : 901 399 5944 1450 BROOKS RD. SE DECISION MADE: 27-APR-12 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K120341(TRADITIONAL) ATTN: VY TRAN PHONE NO : 650 424 5731 3100 HANSEN WAY SE DECISION MADE: 27-APR-12 PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR SHANDONG BAISHENG MEDICAL PRODUCTS510(k) NO: K112294(TRADITIONAL) ATTN: FRANK LIU PHONE NO : 909 548 4828 12390 EAST END AVE. SE DECISION MADE: 27-APR-12 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER NEPHROS, INC. 510(k) NO: K112314(TRADITIONAL) ATTN: GREG COLLINS PHONE NO : 201 343 5202 41 GRAND AVE. SE DECISION MADE: 27-APR-12 RIVER EDGE NJ 07661 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOGATOR ADVANTAGE IRRIGATION PUMP BYRNE MEDICAL, INC. 510(k) NO: K113119(TRADITIONAL) ATTN: BRENT GEIGER PHONE NO : 763 553 3345 14605 28TH AVENUE NORTH SE DECISION MADE: 27-APR-12 MINNEAPOLIS MN 55442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICASE CONNECT MATERIALISE N.V. 510(k) NO: K113599(TRADITIONAL) ATTN: ALEXANDRA RAZZHIVINA PHONE NO : 321 639 6280 TECHNOLOGIELAAN 15 SE DECISION MADE: 27-APR-12 LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUDXA2 LONE OAK MEDICAL TECHNOLOGIES, LLC510(k) NO: K113616(TRADITIONAL) ATTN: DAVID COMLEY PHONE NO : 215 230 7607 3805 OLD EASTON ROAD SE DECISION MADE: 27-APR-12 DOYLESTOWN PA 18902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENESIS REUSABLE RIGID CONTAINER SYSTEM CAREFUSION 2200, INC. 510(k) NO: K112535(TRADITIONAL) ATTN: KATE FULLER PHONE NO : 847 473 7334 1500 WAUKEGAN ROAD SE DECISION MADE: 27-APR-12 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APTUS PROXIMAL HUMERUS SYSTEM MEDARTIS AG 510(k) NO: K120108(TRADITIONAL) ATTN: KEVIN A THOMAS PHONE NO : 858 792 1235 11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 27-APR-12 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRY MOUTH MOUTHWASH DR. FRESH, INC. 510(k) NO: K111250(TRADITIONAL) ATTN: CAMILLE THORNTON PHONE NO : 757 224 0177 MEDICAL DEVICES 144 RESEARCH DRIVESE DECISION MADE: 27-APR-12 HAMPTON VA 23666 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOLUSON S6, VOLUSON S8 GE HEALTHCARE 510(k) NO: K120741(TRADITIONAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 INNOVATION DRIVE SE DECISION MADE: 27-APR-12 WAUWATOSA WI 53233 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE POWDER FREE VINYL EXAM GLOVES CANOPUS MEDICAL SUPPLY CO., LTD. 510(k) NO: K120746(ABBREVIATED) ATTN: GLORIA CHANG PHONE NO : 909 465 9188 18709 GREEN BAT DR., SE DECISION MADE: 27-APR-12 ROWLAND HIGHS CA 91748 510(k) STATEMENT DEVICE: PATHASSIST LIGHT FIBER ENTELLUS MEDICAL, INC. 510(k) NO: K120962(SPECIAL) ATTN: GARRETT P AHLBORG PHONE NO : 763 463 7074 6705 WEDGWOOD COURT NORTH SE DECISION MADE: 27-APR-12 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPIFLO(R) NEOGENIX, LLC 510(k) NO: K120764(SPECIAL) ATTN: SRINIVASAN SARANGAPANI PHONE NO : 781 702 6732 3401 ENTERPRISE PKWY SUITE 340 SE DECISION MADE: 27-APR-12 BEACHWOOD OH 44122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET SURGICAL APPLIANCE INDUSTRIES, INC510(k) NO: K121106(TRADITIONAL) ATTN: GARY PARSONS PHONE NO : 800 888 0458 3960 ROSSLYN DR. SE DECISION MADE: 27-APR-12 CINCINNATI OH 45209 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL HORIBA ABX S.A.S. 510(k) NO: K110530(ABBREVIATED) ATTN: CAROLINE FERRER PHONE NO : 330 467 141843 PARC EUROMEDECINE RUE DU CADUCEE-BSE DECISION MADE: 30-APR-12 MONTPELLIER CEDEX 4, HERAULT FR510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EQUINOX RELIEVE O-TWO MEDICAL TECHNOLOGIES, INC. 510(k) NO: K113687(TRADITIONAL) ATTN: DAVID ZHANG PHONE NO : 905 677 9410 7575 KIMBEL ST. SE DECISION MADE: 30-APR-12 MISSISSAUGA CA L5S 1C8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION BAUSCH & LOMB, INC. 510(k) NO: K112909(TRADITIONAL) ATTN: TRICIA GARRETT PHONE NO : 585 338 6706 1400 NORTH GOODMAN ST. SE DECISION MADE: 30-APR-12 ROCHESTER NY 14609 3547 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K2 MEDICAL VASCULAR CLAMPS K2 MEDICAL GMBH & CO. KG 510(k) NO: K120492(TRADITIONAL) ATTN: PETER FETZER PHONE NO : 497 462 200490 UNTER BUCHSTEIG 3A SE DECISION MADE: 30-APR-12 TUTTLINGEN GM 78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERED MUSCLE STIMULATOR VALMED, SA 510(k) NO: K112148(TRADITIONAL) ATTN: CARL MAGNELL PHONE NO : 412 720 36581 AVE DE TOURBILLON 34 SE DECISION MADE: 30-APR-12 SION, VALAIS SZ CH 1950 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE INTUITIVE SURGICAL, INC. 510(k) NO: K120215(SPECIAL) ATTN: KIM T SERVANCE PHONE NO : 408 523 2100 950 KIFER RD. SE DECISION MADE: 30-APR-12 SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 253 TOTAL WITH SUMMARIES 230 TOTAL WITH STATEMENTS 23
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