Medical Devices
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August 2011 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD August 2011 DEVICE: IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K101572(TRADITIONAL) ATTN: CLARE SANTULLI PHONE NO : 914 524 2701 511 BENEDICT AVENUE SE DECISION MADE: 01-AUG-11 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20 A PLUS MEDICAL 510(k) NO: K110383(TRADITIONAL) ATTN: THOMAS C LOESCHER PHONE NO : 760 930 0425 5431 AVENIDA ENCINAS SUITE G SE DECISION MADE: 01-AUG-11 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH SMITH & NEPHEW, INC. 510(k) NO: K110958(TRADITIONAL) ATTN: LAURA REYNOLDS PHONE NO : 727 329 7702 970 LAKE CARILLON DR. SUITE 110 SE DECISION MADE: 01-AUG-11 ST. PETERSBURG FL 33716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CURE CATHETER CURE MEDICAL LLC. 510(k) NO: K110653(TRADITIONAL) ATTN: ROBYN SCOPIS PHONE NO : 949 262 0411 3722 AVENUE SAUSALITO SE DECISION MADE: 01-AUG-11 IRVINE CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS) INTRICON DATRIX CORPORATION 510(k) NO: K111160(TRADITIONAL) ATTN: TANYA O'BRIEN PHONE NO : 813 645 2855 962 ALLEGRO LANE SE DECISION MADE: 01-AUG-11 APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BENELLI ACCESS DEVICE VASCULAR SOLUTIONS, INC. 510(k) NO: K111334(TRADITIONAL) ATTN: JENNIFER RUETHER PHONE NO : 763 646 4300 6464 SYCAMORE COURT SE DECISION MADE: 01-AUG-11 MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K111745(SPECIAL) ATTN: CLAY ANSELMO PHONE NO : 303 223 4303 555 ZANG STREET SUITE 100 SE DECISION MADE: 01-AUG-11 LAKEWOOD CO 80228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIMEWIRE PRESTIGE PLUS VOLCANO CORPORATION 510(k) NO: K111395(SPECIAL) ATTN: MARILYN POURAZAR PHONE NO : 858 720 4116 3661 VALLEY CENTER DR SUITE 200 SE DECISION MADE: 01-AUG-11 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYPHILIS HEALTH CHECK DIAGNOSTICS DIRECT, LLC. 510(k) NO: K102400(TRADITIONAL) ATTN: GARY LEHNUS PHONE NO : 570 620 0198 150 CHERRY LANE RD SE DECISION MADE: 01-AUG-11 EAST STROUDSBURG PA 18301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS A&D COMPANY, LTD. 510(k) NO: K111686(SPECIAL) ATTN: JERRY WANG PHONE NO : 408 518 5113 1756 AUTOMATION PARKWAY SE DECISION MADE: 01-AUG-11 SAN JOSE CA 9513 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOLITH I-MOVE EDAP TMS FRANCE 510(k) NO: K111808(TRADITIONAL) ATTN: HOLSTEIN HOWARD PHONE NO : 202 637 5813 COLUMBIA SQUARE 555 THIRTEENTH STRSE DECISION MADE: 01-AUG-11 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: B1P ADHESIVE PENTRON CLINICAL 510(k) NO: K111431(TRADITIONAL) ATTN: WENDY GARMAN PHONE NO : 714 516 7602 1717 WEST COLLINS AVENUE SE DECISION MADE: 01-AUG-11 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: "UNITED" U2 XPE TOTAL KNEE SYSTEM UNITED ORTHOPEDIC CORPORATION 510(k) NO: K103733(TRADITIONAL) ATTN: FANG-YUAN HO PHONE NO : 886 3 5773351 NO 57, PARK AVE 2, SCIENCE PARK SE DECISION MADE: 02-AUG-11 HSINCHU TW 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR GE HEALTHCARE FINLAND OY 510(k) NO: K103802(TRADITIONAL) ATTN: TATJA PASANEN PHONE NO : 358 10 3942243 KUORTANEENKATU 2 SE DECISION MADE: 02-AUG-11 HELSINKI FI FIN-00510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGMA STERILIZATION POUCH & ROLL SIGMA MEDICAL SUPPLIES CORP. 510(k) NO: K102158(TRADITIONAL) ATTN: UTA SHIH PHONE NO : 886 7 3113389 # 15-2, LN 26, MINEYUAN 1ST RD LINSE DECISION MADE: 02-AUG-11 KAOHSIUNG TW 802 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANCHORWIRE GUIDEWIRE LAKE REGION MEDICAL 510(k) NO: K111288(TRADITIONAL) ATTN: MATHEW PEXA PHONE NO : 952 448 5111 340 LAKE HAZELTINE DRIVE SE DECISION MADE: 02-AUG-11 CHASKA MN 55318 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LO-BAK TRAX ROLAND F BERTHIAUME, DC 510(k) NO: K110858(TRADITIONAL) ATTN: ROLAND F BERTHIAUME PHONE NO : 413 896 2485 585 COOLEY STREET SE DECISION MADE: 02-AUG-11 SPRINGFIELD MA 01128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM DIRECT DIGITAL IMAGING TECHNOLOGY 510(k) NO: K110801(SPECIAL) ATTN: LIKUN FU PHONE NO : 861 088 856955 #33 BLDG. YUQUAN WISDOM VALE TSINGSE DECISION MADE: 02-AUG-11 BEIJING CH 100097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MESA SPINAL SYSTEM (KEYSTONE RODS) K2M, INC. 510(k) NO: K110991(SPECIAL) ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR.,SE SUITE F-1 SE DECISION MADE: 02-AUG-11 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX DISTAL EXTREMITY PLATE SYSTEM ARTHREX, INC. 510(k) NO: K111253(TRADITIONAL) ATTN: COURTNEY SMITH PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 02-AUG-11 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM PHYGEN, LLC 510(k) NO: K110679(SPECIAL) ATTN: HARTMUT LOCH PHONE NO : 949 752 7885 2301 DUPONT DRIVE SUITE 510 SE DECISION MADE: 02-AUG-11 IRVINE CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE KUNSHAN JIEHONG NONWOVEN PRODUCT C510(k) NO: K111067(TRADITIONAL) ATTN: GLEN FEYE PHONE NO : 619 291 3695 1340 WEST PENNSYLVANIA AVE SE DECISION MADE: 02-AUG-11 SAN DIEGO CA 92103 510(k) STATEMENT DEVICE: VANTAGE TITAN 3T TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K102489(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714 669 7808 2241 MICHELLE DR SE DECISION MADE: 02-AUG-11 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VU C*POD INTERVERTEBRAL BODY FUSION DEVICE THEKEN SPINE LLC 510(k) NO: K111675(SPECIAL) ATTN: DALE DAVISON PHONE NO : 330 239 7700 1153 MEDINA RD. SE DECISION MADE: 02-AUG-11 MEDINA OH 44256 0000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR SHENZHEN DONGDIXIN TECHNOLOGY CO.,510(k) NO: K110707(TRADITIONAL) ATTN: KANG JIAN PING PHONE NO : 86 755 27652471 NO. 3 BUILDING, XILIYIANGGUANG INDSE DECISION MADE: 03-AUG-11 SHENZHEN GUANGDONG CH 518108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS ETHICON ENDO-SURGERY, INC. 510(k) NO: K111195(TRADITIONAL) ATTN: DENNIS HAHN PHONE NO : 513 337 3134 4545 CREEK RD. SE DECISION MADE: 03-AUG-11 CINCINNATI OH 45242 2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KNEEHAB XP BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K110350(TRADITIONAL) ATTN: ANNE-MARIE KEENAN PHONE NO : 353 91 774300 PARKMORE BUSINESS PARK, WEST SE DECISION MADE: 03-AUG-11 GALWAY EI EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001 ATLAS MEDICAL 510(k) NO: K102760(TRADITIONAL) ATTN: NOUR AL-AHWAL PHONE NO : 962 640 26468 KING ABDULLAH II INDUS. ESTATE SAHSE DECISION MADE: 03-AUG-11 AMMAN JO 11512 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TANDA MAX OTC SYSTEM PHAROS LIFE CORPORATION 510(k) NO: K110735(TRADITIONAL) ATTN: JOHNATHAN S KAHAN PHONE NO : 202 637 5794 555 THIRTEENTH ST., NW SE DECISION MADE: 03-AUG-11 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BREEZE ELECTRIC TRANSPORT CHAIR MODEL 1025 ELECTRO KINETIC TECHNOLOGIES, LLC 510(k) NO: K111095(TRADITIONAL) ATTN: RAYMOND ERBE PHONE NO : 262 250 7740 W194N11301 MCCORMICK DRIVE SE DECISION MADE: 03-AUG-11 GEMANTOWN WI 53022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000 MEDSHAPE SOLUTIONS 510(k) NO: K101934(TRADITIONAL) ATTN: DON GRIFFIN PHONE NO : 404 583 6889 1575 NORTHSIDE DR. SUITE 440 SE DECISION MADE: 03-AUG-11 ATLANTA GA 30318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONSTRUX EXTERNAL FIXATION DEVICE EBI, LLC 510(k) NO: K111376(TRADITIONAL) ATTN: MARGARET F CROWE PHONE NO : 973 299 9300 100 INTERPACE PKWY. SE DECISION MADE: 03-AUG-11 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT ERAGEN BIOSCIENCES, INC. 510(k) NO: K111527(TRADITIONAL) ATTN: DAVID LIM PHONE NO : 608 203 8919 918 Deming Way, Suite 201 SE DECISION MADE: 03-AUG-11 Madison WI 53717 1944 510(k) STATEMENT DEVICE: TELEMEDCARE HEALTH MONITOR TELEMEDCARE PTY LTD 510(k) NO: K103796(TRADITIONAL) ATTN: STEVEN M MOODY PHONE NO : 614 285 47750 UNIT 7, 6-8 CREWE PLACE SE DECISION MADE: 03-AUG-11 ROSEBERY, NEW SOUTH WALES AS 20510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRICURE CRYO MODULE SYSTEM ATRICURE, INC. 510(k) NO: K112072(TRADITIONAL) ATTN: JAMES L LUCKY PHONE NO : 513 755 5754 6217 CENTRE PARK DRIVE SE DECISION MADE: 03-AUG-11 WEST CHESTER OH 45069 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EKOSONIC ENDOVASCULAR SYSTEM EKOS CORPORATION 510(k) NO: K111705(TRADITIONAL) ATTN: JOCELYN KERSTEN PHONE NO : 425 415 3132 11911 North Creek Parkway Sout SE DECISION MADE: 03-AUG-11 Bothell WA 98011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE SYNCRO MEDICAL INNOVATIONS, INC. 510(k) NO: K110005(SPECIAL) ATTN: WILLIAM G MCLAIN PHONE NO : 717 656 9656 342 E MAIN STREET, SUITE 207 SE DECISION MADE: 04-AUG-11 LEOLA PA 17540 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K111043(TRADITIONAL) ATTN: JANICE E BROWN, RAC PHONE NO : 510 624 2582 47900 BAYSIDE PARKWAY SE DECISION MADE: 04-AUG-11 FREMONT CA 94538 6515 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESCULAP SIBD XP SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K111122(TRADITIONAL) ATTN: LISA M BOYLE PHONE NO : 610 984 9274 3773 CORPORATE PWKY. SE DECISION MADE: 04-AUG-11 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNITED UTF STEM UNITED ORTHOPEDIC CORPORATION 510(k) NO: K110245(TRADITIONAL) ATTN: FANG-YUAN HO PHONE NO : 886 357 73351 NO 57, PARK AVE 2, SCIENCE PARK SE DECISION MADE: 04-AUG-11 HSINCHU TW 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) NIHON KOHDEN CORP. 510(k) NO: K110410(TRADITIONAL) ATTN: STEVE GEERDES PHONE NO : 949 580 1555 90 ICON STREET SE DECISION MADE: 04-AUG-11 FOOTHILL RANCH CA 92610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER IQUUM INC 510(k) NO: K111387(TRADITIONAL) ATTN: LINGJUN CHEN PHONE NO : 508 970 0099 700 NICKERSON ROAD SE DECISION MADE: 04-AUG-11 MARLBOROUGH MA 01762 4663 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)... COVIDIEN 510(k) NO: K111372(SPECIAL) ATTN: WING NG PHONE NO : 508 261 6596 15 HAMPSHIRE STREET SE DECISION MADE: 04-AUG-11 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN(R) MICROSTREP PLUS(R) SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K111677(TRADITIONAL) ATTN: JENIFER DAWSON DRISCOLL PHONE NO : 916 374 2545 1584 ENTERPRISE BLVD. SE DECISION MADE: 04-AUG-11 WEST SACRAMENTO CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT) STRYKER CORPORATION 510(k) NO: K111478(SPECIAL) ATTN: TIFFANI ROGERS PHONE NO : 201 760 8206 2 PEARL COURT SE DECISION MADE: 04-AUG-11 ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORIN OPTIMOM MODULAR HEAD CORIN U.S.A. 510(k) NO: K111911(SPECIAL) ATTN: LUCINDA GERBER PHONE NO : 813 977 4469 10500 UNIVERSITY CENTER DR., SUITESE DECISION MADE: 04-AUG-11 TAMPA FL 33612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIMETER C SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K100967(TRADITIONAL) ATTN: BRAD SHEALS PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 05-AUG-11 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY SEDECAL S.A. 510(k) NO: K101517(SPECIAL) ATTN: DANIEL KAMM, P.E. PHONE NO : 239 234 1735 8870 RAVELLO CT SE DECISION MADE: 05-AUG-11 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOPEDIATRICS BLADE PLATE SYSTEM ORTHOPEDIATRICS, CORP 510(k) NO: K110959(TRADITIONAL) ATTN: MARK FOX PHONE NO : 574 268 6379 2850 FRONTIER DRIVE SE DECISION MADE: 05-AUG-11 WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IBIS EXPLORER AND MARKUP SOFTWARE MEDQIA 510(k) NO: K111319(TRADITIONAL) ATTN: MAHTAB FATEMI PHONE NO : 650 743 6848 924 WESTWOOD BLVD SUITE 615 SE DECISION MADE: 05-AUG-11 LOS ANGELES CA 90024 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HEADWAY 27 MICROCATHETER MICRO VENTION, INC. 510(k) NO: K110813(SPECIAL) ATTN: NAOMI GONG PHONE NO : 714 247 8055 1311 VALENCIA AVENUE SE DECISION MADE: 05-AUG-11 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICAL FACE MASK; SURGICAL FACE MASK ANGELINE GROUP LTD. 510(k) NO: K110027(TRADITIONAL) ATTN: MICHAEL LEE PHONE NO : 886 2 28096995 NO.45, MINSHENG RD DANSHUI TOWN SE DECISION MADE: 05-AUG-11 TAIPEI COUNTY TW 251 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREEWAY COMFORT BITE GUARD RANDMARK DENTAL PRODUCTS, LLC 510(k) NO: K110468(TRADITIONAL) ATTN: NORMAN F ESTRIN PHONE NO : 301 279 2899 9109 COPENHAVER DRIVE SE DECISION MADE: 05-AUG-11 POTOMAC MD 20854 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRAINLAB TRAUMA BRAINLAB AG 510(k) NO: K110204(TRADITIONAL) ATTN: ALEXANDER SCHWIERSCH PHONE NO : 498 999 15680 KAPELLENSTRASSE 12 SE DECISION MADE: 05-AUG-11 FELDKIRCHEN GM 85622 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ST AIA-PACK DHEA-S CALIBRATOR SET TOSOH BIOSCIENCE, INC. 510(k) NO: K111762(ABBREVIATED) ATTN: JUDITH K OGDEN PHONE NO : 650 636 8112 6000 SHORELINE COURT SUITE 101 SE DECISION MADE: 05-AUG-11 SOUTH SAN FRANCISCO CA 94080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K112054(SPECIAL) ATTN: PAUL BIGGINS PHONE NO : 714 669 7808 2441 MICHELLE DR SE DECISION MADE: 05-AUG-11 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECG-6 SERIES ELECTROCARDIOGRAPH ADVANCED INSTRUMENTATIONS, INC. 510(k) NO: K112135(TRADITIONAL) ATTN: JORGE MILLAN PHONE NO : 305 925 1260 601 WEST 20 ST SE DECISION MADE: 05-AUG-11 HIALEAH FL 33010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPAX NEXT GENERATION AGFA HEALTHCARE N.V. 510(k) NO: K111945(TRADITIONAL) ATTN: JODI COLEMAN PHONE NO : 519 746 6210 SEPTESTRAAT 27 SE DECISION MADE: 05-AUG-11 MORTSEL BE B 2640 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GLIASITE RTS ISORAY MEDICAL, INC. 510(k) NO: K111931(SPECIAL) ATTN: FREDRIC G SWINDLER PHONE NO : 509 375 1202 350 HILLS ST., SUITE 106 SE DECISION MADE: 05-AUG-11 RICHLAND WA 99354 5411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES MAUNA KEA TECHNOLOGIES INC. 510(k) NO: K111047(SPECIAL) ATTN: CHRIS TIHANSKY PHONE NO : 215 279 8415 660 NEWTOWN-YARDLEY RD. SUITE 107 SE DECISION MADE: 08-AUG-11 NEWTON PA 18940 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS INTRA-LOCK INTERNATIONAL, INC. 510(k) NO: K111199(TRADITIONAL) ATTN: ANGELA BLACKWELL PHONE NO : 704 450 9934 6560 WEST ROGERS CIRCLE SE DECISION MADE: 08-AUG-11 BOCA RATON FL 33487 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANTLIA III WOUND TREATMENT SYSTEM INNOVATIVE THERAPIES, INC. 510(k) NO: K111333(SPECIAL) ATTN: JUDITH HARBOUR PHONE NO : 240 396 5500 12 MEEM AVE, SUITE C SE DECISION MADE: 08-AUG-11 GAITHERSBURG MD 20877 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR ROG SPORTS MEDICINE, INC. 510(k) NO: K111590(SPECIAL) ATTN: CURTIS RAYMOND PHONE NO : 203 922 0105 80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 08-AUG-11 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM SYNTHES (USA) 510(k) NO: K111540(TRADITIONAL) ATTN: THOMAS N SHEA PHONE NO : 610 719 6809 1301 GOSHEN PARKWAY SE DECISION MADE: 08-AUG-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 CONMED LINVATEC 510(k) NO: K111779(TRADITIONAL) ATTN: JOHN CUSACK PHONE NO : 727 399 5266 11311 CONCEPT BOULEVARD SE DECISION MADE: 08-AUG-11 LARGO FL 33773 4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP STRYKER 510(k) NO: K112059(SPECIAL) ATTN: VALERIE GIAMBANCO PHONE NO : 201 831 6275 325 CORPORATE DRIVE SE DECISION MADE: 08-AUG-11 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 ABBOTT MOLECULAR, INC. 510(k) NO: K100015(TRADITIONAL) ATTN: PAMELA L SWATKOWSKI PHONE NO : 224 361 7013 1300 EAST TOUHY AVENUE SE DECISION MADE: 09-AUG-11 DES PLAINES IL 60018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 ANDON MEDICAL CO., LTD. 510(k) NO: K101307(TRADITIONAL) ATTN: YI LIU PHONE NO : 86 22 87612426 04-23-3 AIRPORT INDUSTRIAL PK SE DECISION MADE: 09-AUG-11 TIANJIN CH 300381 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRESCENT (R) SPINAL SYSTEM TITANIUM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K110543(SPECIAL) ATTN: BECKY RONNER PHONE NO : 901 399 2757 1800 PYRAMID PLACE SE DECISION MADE: 09-AUG-11 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLLACARE DENTAL INNOCOLL PHARMACEUTICALS LTD 510(k) NO: K110388(TRADITIONAL) ATTN: AARON WYSE PHONE NO : 353 090 6666091 MIDLANDS RESEARCH AND INNOVATION CSE DECISION MADE: 09-AUG-11 ATHLONE, CO. WESTMEATH EI EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER RESPIRONICS NEW JERSEY, INC. 510(k) NO: K110293(TRADITIONAL) ATTN: LAUREN ZIEGLER PHONE NO : 973 581 6008 5 WOOD HOLLOW ROAD SE DECISION MADE: 09-AUG-11 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVIAID(TM) BGC DEVICE SMART MEDICAL SYSTEMS, LTD. 510(k) NO: K111760(SPECIAL) ATTN: ADVA YOSELZON PHONE NO : 972 974 44321 10 HAYETSIRA STREET SE DECISION MADE: 09-AUG-11 RAANANA IS 43663 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE ARTHROCARE CORPORATION 510(k) NO: K111044(TRADITIONAL) ATTN: LAURA KASPEROWICZ PHONE NO : 949 585 2406 15285 ALTON PARKWAY SUITE 209 SE DECISION MADE: 09-AUG-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METASURG SUBTALAR IMPLANT METASURG 510(k) NO: K111265(TRADITIONAL) ATTN: JOSHUA SCOTT PHONE NO : 281 398 5656 16350 PARK TEN PL., SUITE 101 SE DECISION MADE: 09-AUG-11 HOUSTON TX 77084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYBOW READER, MODELS 300 & 720 DFI CO., LTD. 510(k) NO: K102188(TRADITIONAL) ATTN: YANG HO-DONG PHONE NO : 082 2 5663360 #821 SAMIL PLAZA, 837-26 YEUKSAM-DSE DECISION MADE: 09-AUG-11 GANGNAM-GU, SEOUL KS 135-937 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAPPHIRE ORBUSNEICH MEDICAL, INC. 510(k) NO: K103657(TRADITIONAL) ATTN: JOHN PAZIENZA PHONE NO : 954 730 0711 5363 N.W. 35TH AVE. SE DECISION MADE: 09-AUG-11 FT. LAUDERDALE FL 33309 6315 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM TEM INNOVATIONS GMBH 510(k) NO: K101533(TRADITIONAL) ATTN: VOLKER-JOACHIM FRIEMERT PHONE NO : 498 945 42950 MARTIN-KOLLAR STR 13-15 SE DECISION MADE: 10-AUG-11 MUNICH, BAVARIA/UPPER BAVARIA G510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) INNOVATIVE GLOVES CO; LTD 510(k) NO: K111158(TRADITIONAL) ATTN: RAJEEV SOOD PHONE NO : 667 450 2251 830 MOO 4 SANAMBIN-BANKLANG RD KUASE DECISION MADE: 10-AUG-11 HATYAI, SONGKHLA TH 90110 510(k) STATEMENT DEVICE: SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (YELLOW / BLUE / WHITE / MAGENTA / CLEAR - NON COLORED) SHANDONG BLUE SAIL INNOVATION CO.,510(k) NO: K103619(TRADITIONAL) ATTN: YONGCHEN ZHANG PHONE NO : 865 363 658588 EAST SIDE OF XING'AN ROAD, DONGCHESE DECISION MADE: 10-AUG-11 WEIFANG, SHANDONG CH 262600 510(k) STATEMENT DEVICE: RALCO RALCO S.R.L. 510(k) NO: K110856(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO CT SE DECISION MADE: 10-AUG-11 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN HORIBA ABX S.A.S. 510(k) NO: K110137(ABBREVIATED) ATTN: CAROLINE FERRER PHONE NO : 330 467 141843 PARC EUROMEDECINE RUE DU CADUCEE-BSE DECISION MADE: 10-AUG-11 MONTPELLIER CEDEX 4, HERAULT FR510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIOLOGICAL IMAGE PROCESSING SYSTEM VATECH CO., LTD. 510(k) NO: K102078(TRADITIONAL) ATTN: DAVE KIM PHONE NO : 832 623 2099 333 MEADOWLANDS PARKWAY, #303 SE DECISION MADE: 10-AUG-11 SECAUCUS NJ 07094 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C7 XR IMAGING SYSTEM LIGHTLAB IMAGING,INC. 510(k) NO: K111201(TRADITIONAL) ATTN: BRYAN COWELL PHONE NO : 978 692 1000 ONE TECHNOLOGY PARK DRIVE SE DECISION MADE: 10-AUG-11 WESTFORD MA 01886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) SYNTHES (USA) PRODUCTS LLC 510(k) NO: K111437(TRADITIONAL) ATTN: ANGELA F LASSANDRO PHONE NO : 610 719 6854 1301 GOSHEN PKWY. SE DECISION MADE: 10-AUG-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER BRIDGEPOINT MEDICAL 510(k) NO: K111963(SPECIAL) ATTN: JILL MUNSINGER PHONE NO : 763 225 8500 2800 CAMPUS DR STE 50 SE DECISION MADE: 10-AUG-11 PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP) INFIMED, INC. 510(k) NO: K112180(SPECIAL) ATTN: CATHERINE MULCAHY PHONE NO : 315 453 4545 121 METROPOLITAN DR. SE DECISION MADE: 10-AUG-11 LIVERPOOL NY 13088 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUCINA MODEL MELODI GENADYNE BIOTECHNOLOGIES, INC. 510(k) NO: K102516(TRADITIONAL) ATTN: CHIEN MING(ANDREW)GOH PHONE NO : 800 208 2025 65 WATERMILL LANE SE DECISION MADE: 11-AUG-11 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIO COLOR 2MP BARCO NV 510(k) NO: K111991(TRADITIONAL) ATTN: LIEVEN DE WANDEL PHONE NO : 325 623 3459 35 PRESIDENT KENNEDYPARK SE DECISION MADE: 11-AUG-11 KORTRIJK BE 8500 510(k) STATEMENT DEVICE: UNIVERSAL CLAMP SPINAL FIXATION SYSTEM ZIMMER SPINE 510(k) NO: K110348(TRADITIONAL) ATTN: ELSA A LINKE PHONE NO : 952 830 6205 7375 BUSH LAKE ROAD SE DECISION MADE: 11-AUG-11 EDINA MN 55439 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM SPINEART 510(k) NO: K111127(SPECIAL) ATTN: FRANCK PENNESI PHONE NO : 412 279 94025 COINTRIN 20 ROUTE DE PRE-BOIS CP18SE DECISION MADE: 11-AUG-11 GENEVA SZ 1215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORIGIN ZIRCONIA B&D DENTAL TECHNOLOGIES 510(k) NO: K110719(ABBREVIATED) ATTN: JOON HWANG PHONE NO : 801 214 3005 2371 S. PRESIDENTS DR., STE. E SE DECISION MADE: 11-AUG-11 WEST VALLEY UT 84119 510(k) STATEMENT DEVICE: DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES STARBOARD MEDICAL, LLC 510(k) NO: K111282(TRADITIONAL) ATTN: ANTHONY BERAN PHONE NO : 714 283 3099 22845 SAVI RANCH PKWY SUITE H SE DECISION MADE: 11-AUG-11 Yorba Linda CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EEVATM PETRI DISH AUXOGYN, INC. 510(k) NO: K103028(TRADITIONAL) ATTN: ROBERT NEWMAN PHONE NO : 650 641 2429 1490 O'BRIEN DRIVE SUITE A SE DECISION MADE: 11-AUG-11 MENLO PARK CA 94545 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFILL GRAFT DELIVERY SYSTEM PINNACLE SPINE GROUP, LLC 510(k) NO: K111632(TRADITIONAL) ATTN: REBECCA K SPINE PHONE NO : 760 809 5178 1601 ELM STREET, SUITE 300 SE DECISION MADE: 11-AUG-11 DALLAS TX 75201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMBRYOSCOPE UNISENSE FERTILITECH A/S 510(k) NO: K111715(TRADITIONAL) ATTN: METTE MUNCH PHONE NO : 458 944 520 TUEAGER 1 SE DECISION MADE: 11-AUG-11 ARRHUS N DA DK-8200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANODIZED HEALING COLLAR ZIMMER DENTAL INC. 510(k) NO: K111852(SPECIAL) ATTN: MELISSA BURBAGE PHONE NO : 760 929 4300 1900 ASTON AVE. SE DECISION MADE: 11-AUG-11 CARLSBAD CA 92008 7308 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCAL STREAMLINE 577 (WITH ACCESSORIES) TOPCON MEDICAL LASER SYSTEMS, INC 510(k) NO: K111108(TRADITIONAL) ATTN: JOHN JOSSY PHONE NO : 408 235 8202 3130 CORONADO DRIVE SE DECISION MADE: 11-AUG-11 SANTA CLARA CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WILDCAT CATHETER AVINGER, INC. 510(k) NO: K111338(TRADITIONAL) ATTN: KIT CARIQUITAN PHONE NO : 408 400 0856 755 MATHILDA AVENUE SUITE 100 SE DECISION MADE: 11-AUG-11 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES) SOFRADIM PRODUCTION 510(k) NO: K110663(TRADITIONAL) ATTN: JAMES MCMAHON PHONE NO : 781 839 1787 15 CROSBY DRIVE SE DECISION MADE: 11-AUG-11 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 AST-ST LINEZOLID BIOMERIEUX, INC. 510(k) NO: K111599(TRADITIONAL) ATTN: NATHAN HARDESTY PHONE NO : 314 731 8666 595 ANGLUM RD. SE DECISION MADE: 12-AUG-11 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRIVO XR385 GE MEDICAL SYSTEMS, LLC 510(k) NO: K103448(TRADITIONAL) ATTN: JOHN L SCHMIDT PHONE NO : 262 548 4964 3000 N GRANDVIEW BLVD. SE DECISION MADE: 12-AUG-11 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENTRYSUITE PRODUCT LINE CAREFUSION GERMANY 234 GMBH 510(k) NO: K111053(TRADITIONAL) ATTN: ELMAR NIEDERMEYER PHONE NO : 499 314 972361 LEIBNIZSTRASSE 7 SE DECISION MADE: 12-AUG-11 HOECHBERG, BAVARIA GM 97204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUSOM NOVASOM, INC. 510(k) NO: K110486(TRADITIONAL) ATTN: ROGER K RICHARDSON PHONE NO : 410 590 0443 801 CROMWELL PARK DRIVE SE DECISION MADE: 12-AUG-11 GLEN BURNIE MD 21061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER MARVAO MEDICAL DEVICES, LTD. 510(k) NO: K110627(TRADITIONAL) ATTN: MARYBETH GAMBER PHONE NO : 508 351 8632 368 WEST MAIN STREET SUITE 7 SE DECISION MADE: 12-AUG-11 NORTHBORO MA 01532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE) PT. MAHAKARYA INTI BUANA 510(k) NO: K111300(TRADITIONAL) ATTN: LINA NG PHONE NO : 62 61 30007150 DALU 10, DELI SERDANG T. MORAWA SE DECISION MADE: 12-AUG-11 SUMATERA UTARA ID 20362 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM STERIS CORPORATION 510(k) NO: K102330(TRADITIONAL) ATTN: ROBERT F SULLIVAN PHONE NO : 440 392 7695 5960 HEISLEY ROAD SE DECISION MADE: 12-AUG-11 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS STRAUMANN USA 510(k) NO: K110580(TRADITIONAL) ATTN: ELAINE ALAN PHONE NO : 978 747 2513 60 MINUTEMAN ROAD SE DECISION MADE: 12-AUG-11 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KIDS ROCK 3 CHAIR PRIDE MOBILITY PRODUCTS CORP. 510(k) NO: K111739(SPECIAL) ATTN: KIMBERLY BLAKE PHONE NO : 570 655 5574 182 SUSQUEHANNA AVE. SE DECISION MADE: 12-AUG-11 EXETER PA 18643 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM BOSTON SCIENTIFIC CORP. 510(k) NO: K112103(SPECIAL) ATTN: HARLAN JONES PHONE NO : 763 255 0027 ONE SCIMED PLACE SE DECISION MADE: 12-AUG-11 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE POWDER FREE EXAMINATION GLOVES HARTALEGA SDN BHD 510(k) NO: K110758(TRADITIONAL) ATTN: NURUL AISYAH KONG BT ABDULLPHONE NO : 603 327 10277X2200 NO. 7, KAWASAN PERUSAHAAN SURIA SE DECISION MADE: 12-AUG-11 BESTARI JAYA, SELANGOR MY 45600510(k) STATEMENT DEVICE: NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202 HSINER CO., LTD. 510(k) NO: K102120(TRADITIONAL) ATTN: TOM SHANKS PHONE NO : 951 506 2674 29201 VIA NORTE SE DECISION MADE: 12-AUG-11 TEMECULA CA 92591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TECA ELITE DISPOSABLE CONCENTRIC NEEDLES CAREFUSION 209, INC. 510(k) NO: K112034(SPECIAL) ATTN: GLEN HERMANSON PHONE NO : 608 829 8606 1850 Deming Way SE DECISION MADE: 12-AUG-11 Middleton WI 53562 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIRPRIME NORITAKE CO., INC. 510(k) NO: K111383(TRADITIONAL) ATTN: IVAN WASSERMAN PHONE NO : 202 585 6529 700 12 STREET, N.W., SUITE 1100 SE DECISION MADE: 12-AUG-11 WASHINGTON DC 20005 510(k) STATEMENT DEVICE: ISROBOT MONA LISA BIOBOT SURGICAL PTE LTD 510(k) NO: K111347(TRADITIONAL) ATTN: CHERITA JAMES PHONE NO : 703 562 9800 901 KING ST SUITE 200 SE DECISION MADE: 12-AUG-11 ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC EXACTECH, INC. 510(k) NO: K103699(TRADITIONAL) ATTN: SHING JEN TAI, PHD PHONE NO : 352 377 1140 2320 N.W. 66TH CT. SE DECISION MADE: 12-AUG-11 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDILED MINI MEDIX I.C.S.A. 510(k) NO: K103735(TRADITIONAL) ATTN: JAMES H KNAUSS PHONE NO : 832 675 9281 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 15-AUG-11 HOUSTON TX 77071 3404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRANIAL REMOLDING ORTHOSIS ORTHOTIC CARE SERVICES, LLP 510(k) NO: K111247(TRADITIONAL) ATTN: SCOTT HINSHON PHONE NO : 651 291 9000 360 SHERMAN STREET, SUITE 299 SE DECISION MADE: 15-AUG-11 ST.PAUL MN 55102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM OSTEOMED L.P. 510(k) NO: K111176(SPECIAL) ATTN: PIEDAD PENA PHONE NO : 972 677 4600 3885 ARAPAHO RD. SE DECISION MADE: 15-AUG-11 ADDISON TX 75001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPIDPOINT 405 NEONATAL BILIRUBIN SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K110277(TRADITIONAL) ATTN: STEVEN GOLDBERG PHONE NO : 781 269 3941 2 EDGEWATER DRIVE SE DECISION MADE: 15-AUG-11 NORWOOD MA 02062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ION HEALTH USB INSTA-SCAN THERMOMETER TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K111974(SPECIAL) ATTN: TELING HSU PHONE NO : 886 266 258188 3F,5F, NO.127 WUGONG 2ND RD, WUGU SE DECISION MADE: 15-AUG-11 NEW TAIPEI CITY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA) OMEGA LABORATORIES, INC. 510(k) NO: K101973(TRADITIONAL) ATTN: ROBERT J BARD PHONE NO : 248 563 5040 PO BOX 506 SE DECISION MADE: 16-AUG-11 SOUTH LYON MI 48178 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDO HEAD MEDACTA INTERNATIONAL 510(k) NO: K111145(TRADITIONAL) ATTN: ADAM GROSS PHONE NO : 805 437 7085 4725 CALLE QUETZAL, UNIT B SE DECISION MADE: 16-AUG-11 CAMARILLO CA 93012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUMATCH PERSONALIZED SOLUTIONS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K110397(TRADITIONAL) ATTN: NANCY S FRIDDLE PHONE NO : 574 371 4923 700 ORTHOPAEDIC DRIVE SE DECISION MADE: 16-AUG-11 WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HAIRMAX DUAL 12 LEXINGTON INTERNATIONAL, LLC 510(k) NO: K111714(TRADITIONAL) ATTN: CASPER E ULDRICKS ESQ. PHONE NO : 202 518 6385 1400 SIXTEENTH STREET, NW SUITE 40SE DECISION MADE: 16-AUG-11 WASHINGTON DC 20036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS NOVA BIOMEDICAL CORP. 510(k) NO: K100602(TRADITIONAL) ATTN: PAUL W MACDONALD PHONE NO : 781 894 0800 200 PROSPECT ST. SE DECISION MADE: 17-AUG-11 WALTHAM MA 02454 9141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA CHEMISTRY FERRITIN (FRT) METHOD SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K110736(TRADITIONAL) ATTN: KIRA GORDON PHONE NO : 914 524 2996 511 BENEDICT AVENUE SE DECISION MADE: 17-AUG-11 TARRYTOWN NY 10509 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM OSTIAL CORPORATION 510(k) NO: K111284(TRADITIONAL) ATTN: MARK SMUTKA PHONE NO : 650 903 9100 510 CLYDE AVENUE SE DECISION MADE: 17-AUG-11 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES) K2M, INC. 510(k) NO: K111135(SPECIAL) ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR.,SE SE DECISION MADE: 17-AUG-11 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL E SERIES ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K111594(TRADITIONAL) ATTN: CHUCK KOLIFRATH PHONE NO : 978 421 9786 269 MILL ROAD SE DECISION MADE: 17-AUG-11 CHELMSFORD MA 01824 4105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT COLOPLAST A/S 510(k) NO: K111881(TRADITIONAL) ATTN: JANELL A COLLEY PHONE NO : 612 287 4211 1601 WEST RIVER ROAD N SE DECISION MADE: 17-AUG-11 MINNEAPOLIS MN 55411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIBERNET EMBOLIC PROTECTION DEVICE LUMEN BIOMEDICAL, INC. 510(k) NO: K111987(SPECIAL) ATTN: MICHELLE STRAIGHT PHONE NO : 763 746 9551 10900 73RD AVE NORTH SUITE 150 SE DECISION MADE: 17-AUG-11 MAPLE GROVE MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVOLVE ADDITIONAL IMPLANTS GLOBUS MEDICAL, INC. 510(k) NO: K111449(SPECIAL) ATTN: SARAH MARIE FITZGERALD PHONE NO : 610 930 1800 2560 GENERAL ARMISTEAD AVE. VALLEYSE DECISION MADE: 17-AUG-11 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER TELEFLEX MEDICAL, INC. 510(k) NO: K111900(TRADITIONAL) ATTN: SUZANNE SCHORLE PHONE NO : 610 378 0131 2400 BERNVILLE ROAD SE DECISION MADE: 17-AUG-11 READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K111083(ABBREVIATED) ATTN: MICHAEL ASMALSKY PHONE NO : 497 031 4631277 HEWLETT-PACKARD STR.2 SE DECISION MADE: 17-AUG-11 BOEBLINGEN GM D 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018" GUIDE WIRE 6100-XXXXX, 6100CB-XXXX TRIREME MEDICAL, INC. 510(k) NO: K112281(TRADITIONAL) ATTN: SHIVA ARDAKANI PHONE NO : 925 931 1300 7060 Koll Center Parkway Suite 300SE DECISION MADE: 17-AUG-11 Pleasanton CA 94566 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: REVERE CROSSTOP GLOBUS MEDICAL INC. 510(k) NO: K111479(SPECIAL) ATTN: SARAH M FITZGERALD PHONE NO : 610 930 1800 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 17-AUG-11 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CROSSER RECANALIZATION SYSTEM C.R. BARD, INC. 510(k) NO: K112308(TRADITIONAL) ATTN: TIMOTHY WADE PHONE NO : 480 638 2939 745 N. PASTORIA AVE SE DECISION MADE: 17-AUG-11 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING SENTINELLE MEDICAL, INC. 510(k) NO: K103274(TRADITIONAL) ATTN: CAMERON PIRON PHONE NO : 647 258 3601 555 RICHMOND STREET W SUITE 800, PSE DECISION MADE: 18-AUG-11 TORONTO, ONTARIO CA M5V 3B1 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: IMC INSULIN SYRINGE INTERNATIONAL MEDSURG CONNECTION 510(k) NO: K110882(TRADITIONAL) ATTN: PETER KIM PHONE NO : 847 619 9926 935 N. PLUM GROVE ROAD, SUITE F SE DECISION MADE: 18-AUG-11 SCHAUMBURG IL 60173 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER STERILMED, INC. 510(k) NO: K110076(TRADITIONAL) ATTN: GARRETT AHLBORG PHONE NO : 763 488 3483 11400 73RD AVE. NORTH SE DECISION MADE: 18-AUG-11 MAPLE GROVE MN 55369 5562 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXIS-SHIELD ANTI-CCP AXIS-SHIELD DIAGNOSTICS, LTD. 510(k) NO: K110296(TRADITIONAL) ATTN: CLAIRE I DORA PHONE NO : 441 382 422000 THE TECHNOLOGY PARK LUNA PLACE SE DECISION MADE: 18-AUG-11 DUNDEE, SCOTLAND UK DD2 1XA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMC BLOOD COLLECTION NEEDLE INTERNATIONAL MEDSURG CONNECTION 510(k) NO: K110656(TRADITIONAL) ATTN: PETER KIM PHONE NO : 847 619 9926 935 N PLUM GROVE ROAD SUITE F SE DECISION MADE: 18-AUG-11 SCHAUMBURG IL 60173 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT VELOPEX INTERNATIONAL, INC. 510(k) NO: K111167(TRADITIONAL) ATTN: ANTHONY URELLA PHONE NO : 407 957 3900 105 EAST 17TH ST. SE DECISION MADE: 18-AUG-11 ST. CLOUD FL 34769 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CS 9300, CS 9300C TROPHY 510(k) NO: K103659(TRADITIONAL) ATTN: MARIE-PIERRE LABAT-CAMY PHONE NO : 331 648 08500 4 RUE F. PELLOUTIER CROISSY BEAUBOSE DECISION MADE: 18-AUG-11 MARNE LA VALLEE CEDEX 2 FR 7743510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMR REVERSE SHOULDER SYSTEM LIMACORPORATE S.P.A. 510(k) NO: K110598(TRADITIONAL) ATTN: CHERYL HASTINGS PHONE NO : 574 527 4220 P.O. BOX 696 SE DECISION MADE: 18-AUG-11 WINONA LAKE IN 46590 696 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUEBEAM VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K111106(TRADITIONAL) ATTN: VY TRAN PHONE NO : 650 424 5731 3100 HANSEN WAY SE DECISION MADE: 18-AUG-11 PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM STERIS CORPORATION 510(k) NO: K102394(TRADITIONAL) ATTN: ROBERT SULLIVAN PHONE NO : 440 354 2600 5960 HEISLEY ROAD SE DECISION MADE: 18-AUG-11 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE TRIMARK TRICAM DENTAL IMPLANT ACE SURGICAL SUPPLY COMPANY INC. 510(k) NO: K103790(TRADITIONAL) ATTN: DENISE WILLIAMS PHONE NO : 508 588 3100 1034 PEARL ST. SE DECISION MADE: 18-AUG-11 BROCKTON MA 02401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM... MEDLINE INDUSTRIES, INC. 510(k) NO: K111807(TRADITIONAL) ATTN: MATT CLAUSEN PHONE NO : 847 643 4785 ONE MEDLINE PLACE SE DECISION MADE: 18-AUG-11 MUNDELEIN IL 60060 510(k) STATEMENT DEVICE: SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... TREK DIAGNOSTIC SYSTEMS, LTD. 510(k) NO: K111429(TRADITIONAL) ATTN: CYNTHIA C KNAPP PHONE NO : 216 351 8735 982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 18-AUG-11 CLEVELAND OH 44131 510(k) STATEMENT DEVICE: SYNGO.CT VASCULAR ANALYSIS SIEMENS MEDICAL SOLUTIONS, INC. 510(k) NO: K112020(TRADITIONAL) ATTN: RALF HOFMANN PHONE NO : 49 919 1188170 51 VALLEY STREAM PARKWAY SE DECISION MADE: 18-AUG-11 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK TECHLAB INC., CORPORATE RESEARCH C510(k) NO: K103673(TRADITIONAL) ATTN: DONNA T LINK PHONE NO : 540 953 1664 2001 KRAFT DR. SE DECISION MADE: 18-AUG-11 BLACKSBURG VA 24060 6358 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFOSEND GSM FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K110316(TRADITIONAL) ATTN: JAMES THOMPSON PHONE NO : 649 574 0123 15 MAURICE PAYKEL PLACE, EAST TAMASE DECISION MADE: 19-AUG-11 AUCKLAND NZ 1701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR BIOMET SPORTS MEDICINE 510(k) NO: K110879(TRADITIONAL) ATTN: ELIZABETH WRAY PHONE NO : 574 371 1176 56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 19-AUG-11 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIMED RADIOCARPAL FUSION SYSTEM TRIMED, INC. 510(k) NO: K102785(TRADITIONAL) ATTN: DAVID ANDERSON PHONE NO : 661 312 7150 28337 MAITLAND LANE SE DECISION MADE: 19-AUG-11 SAUGUS CA 91350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TL-CERMIDE SKIN BARRIER EMULSION TRIGEN LABORATORIES, INC. 510(k) NO: K110757(TRADITIONAL) ATTN: GEORGE MCCAULEY PHONE NO : 803 831 7657 248 LATITUDE LANE SUITE 104 SE DECISION MADE: 19-AUG-11 LAKE WYLIE SC 29710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CKMB UDR ASSAY SENTINEL CH. SPA 510(k) NO: K102706(TRADITIONAL) ATTN: FABIO ROTA PHONE NO : 390 234 551448 VIA ROBERT KOCH, 2 SE DECISION MADE: 19-AUG-11 MILANO IT 20152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAXX XDL SYSTEM SPINE WAVE, INC. 510(k) NO: K102315(TRADITIONAL) ATTN: DENISE DUCHENE PHONE NO : 203 712 1847 THREE ENTERPRISE DR. SUITE 210 SE DECISION MADE: 19-AUG-11 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V200 INTELLI-TRAK OPTION RESPIRONICS CALIFORNIA, INC. 510(k) NO: K110795(TRADITIONAL) ATTN: ROBERT M MARSHALL PHONE NO : 724 327 0230 3919 WILLIAM PENN HIGHWAY, SUITE 2SE DECISION MADE: 19-AUG-11 MURRYSVILLE PA 15668 8550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILK'N FX HOME SKINOVATIONS LTD. 510(k) NO: K110301(TRADITIONAL) ATTN: AMIR WALDMAN PH. D. PHONE NO : 972 547 404616 TAVOR BULD. POB 533 SE DECISION MADE: 19-AUG-11 YOKNEAM ILLIT IS 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONAFINE WOUND DRESSING STRATUS PHARMACEUTICAL 510(k) NO: K110172(TRADITIONAL) ATTN: ALBERTO HOYO PHONE NO : 305 254 6793 12379 SW 130TH STREET SE DECISION MADE: 19-AUG-11 MIAMI FL 33186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RSI 4200 REIMERS SYSTEMS, INC. 510(k) NO: K102831(ABBREVIATED) ATTN: NAYIL ALAM PHONE NO : 703 952 0240 8210-D CINDERBED RD. SE DECISION MADE: 19-AUG-11 LORTON VA 22079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTROTORQUE TLC KALTENBACH & VOIGT GMBH 510(k) NO: K103027(TRADITIONAL) ATTN: CLAUDIA ORTIZ PHONE NO : 714 516 7981 1717 WEST COLLINS SE DECISION MADE: 19-AUG-11 ORANGE CA 92687 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFEMUR(R) E CEMENTLESS HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K111698(SPECIAL) ATTN: GREGORY NEAL PHONE NO : 901 290 5812 5677 AIRLINE RD. SE DECISION MADE: 19-AUG-11 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K111699(SPECIAL) ATTN: GREGORY NEAL PHONE NO : 901 290 5812 5677 AIRLINE RD. SE DECISION MADE: 19-AUG-11 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM) SONOMA ORTHOPEDIC PRODUCTS, INC. 510(k) NO: K111550(TRADITIONAL) ATTN: CHARLES L NELSON PHONE NO : 707 526 1335 3589 WESTWIND BLVD SE DECISION MADE: 19-AUG-11 SANTA ROSA CA 95403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLARIS SPINAL SYSTEM BIOMET SPINE (EBI LLC) 510(k) NO: K111957(TRADITIONAL) ATTN: VIVIAN KELLY, RAC PHONE NO : 973 299 9300 100 INTERPACE PARKWAY SE DECISION MADE: 19-AUG-11 PARSIPPANY NJ 07540 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LCCS INSULATED SPINAL NEEDLE (RF CANNULA) LCCS PRODUCTS LIMITED 510(k) NO: K112231(TRADITIONAL) ATTN: FIELD FU PHONE NO : 860 755 86069197 05C FUJAI KANGLE BUILDING NANSHAN SE DECISION MADE: 19-AUG-11 SHENZHEN, GUANGDONG CH 518000 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE CENTRAL MEDICARE SDN BHD 510(k) NO: K103734(TRADITIONAL) ATTN: NICK WANG PHONE NO : 909 860 1908 1930 BREA CANYON ROAD, #240,DIAMONSE DECISION MADE: 19-AUG-11 DIAMOND BAR CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-CUBE SAESHIN PRECISION CO., LTD. 510(k) NO: K111616(TRADITIONAL) ATTN: Y S LEE PHONE NO : 82 53 5872345 #93-15, PAHO-DONG, DALSEO-GU SE DECISION MADE: 19-AUG-11 DAEGU KS 704-220 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K111432(TRADITIONAL) ATTN: ANGELA SMITH PHONE NO : 901 867 4184 5677 AIRLINE RD. SE DECISION MADE: 19-AUG-11 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 HOLOGIC, INC. 510(k) NO: K111508(TRADITIONAL) ATTN: DEBORAH THOMAS PHONE NO : 781 999 7558 35 CROSBY DR. SE DECISION MADE: 19-AUG-11 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM SPINEART 510(k) NO: K112108(SPECIAL) ATTN: FRANK P ENNESI PHONE NO : 41 227 994025 COINTRIN 20 ROUTE DE PRE-BOIS CP18SE DECISION MADE: 19-AUG-11 GENEVA SZ 1215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: P200T OPTOS PLC 510(k) NO: K111628(SPECIAL) ATTN: HOWARD M HOLSTEIN PHONE NO : 202 637 5815 555 THIRTEENTH STREET, NW SE DECISION MADE: 19-AUG-11 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIMAX VERESS NEEDLE UNIMAX MEDICAL SYSTEMS, INC. 510(k) NO: K111441(TRADITIONAL) ATTN: MICHAEL LEE PHONE NO : 886 2 28096995 NO. 45, MINSHEN RD. DANSHUI TOWN SE DECISION MADE: 19-AUG-11 TAIPEI COUNTY TW 251 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUGAIT(TM) SUBTALAR IMPLANT SYSTEM ASCENSION ORTHOPEDIC 510(k) NO: K111799(TRADITIONAL) ATTN: BRADLEY W STRASSER PHONE NO : 512 836 5001 8700 CAMERON RD., STE. 100 SE DECISION MADE: 19-AUG-11 Austin TX 78754 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAVIOS CALCIUM HYDROXIDE CAVITY LINER NEODENTAL CHEMICAL PRODUCTS CO., L510(k) NO: K111668(TRADITIONAL) ATTN: ROBERT SEIPLE PHONE NO : 512 327 9997 611 WEST 5TH STREET SE DECISION MADE: 19-AUG-11 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INBODY BIOSPACE CORPORATION LIMITED 510(k) NO: K110689(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO CT SE DECISION MADE: 19-AUG-11 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITALA CONTINENCE CONTROL DEVICE CONVATEC INC. 510(k) NO: K111365(TRADITIONAL) ATTN: MARK R JAKUBOWSKI PHONE NO : 908 904 2719 200 HEADQUARTERS PARK DR. SE DECISION MADE: 19-AUG-11 SKILLMAN NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROCATHETER NAVILYST MEDICAL, INC. 510(k) NO: K112124(ABBREVIATED) ATTN: WANDA CARPINELLA PHONE NO : 508 658 7929 26 FOREST STREET SE DECISION MADE: 19-AUG-11 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033 BECKMAN COULTER, INC. 510(k) NO: K111952(ABBREVIATED) ATTN: KERRIE S OETTER PHONE NO : 952 368 7585 1000 LAKE HAZELTINE DR. MS R-275-BSE DECISION MADE: 19-AUG-11 CHASKA MN 55318 1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIPOSONIX SYSTEM, MODEL 1 P00XXXX MEDICIS TECHNOLOGIES CORPORATION 510(k) NO: K100874(TRADITIONAL) ATTN: JONATHAN KAHAN PHONE NO : 202 637 5600 COLUMBIA SQUARE 555 13TH STREET NWSE DECISION MADE: 19-AUG-11 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX SCAPHOLUNATE ANCHOR ARTHREX, INC. 510(k) NO: K111661(SPECIAL) ATTN: COURTNEY SMITH PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 19-AUG-11 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE ASAHI INTECC CO., LTD. 510(k) NO: K110584(TRADITIONAL) ATTN: YOSHI TERAI PHONE NO : 949 756 8252 2500 RED HILL SUITE 210 SE DECISION MADE: 22-AUG-11 SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: YOLO CURVE YOLO MEDICAL INC. 510(k) NO: K110342(TRADITIONAL) ATTN: ROBERT J KRZNARIC PHONE NO : 604 542 2200 #245 - 1959 152ND STREET SE DECISION MADE: 22-AUG-11 SURREY, BRITISH COLUMBIA CA V4A510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIEVA SOLO ELITE SINUS BALLOON CATHETER ACCLARENT, INC. 510(k) NO: K111254(TRADITIONAL) ATTN: KIM KY PHONE NO : 650 687 4473 1525-B O'BRIEN DR. SE DECISION MADE: 22-AUG-11 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOSTON BAND BOSTON BRACE INTL., INC. 510(k) NO: K111609(TRADITIONAL) ATTN: JAMES WYNNE PHONE NO : 800 262 2235 20 LEDIN DR. SE DECISION MADE: 22-AUG-11 AVON MA 02322 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TALON DISTALFIX PROXIMAL FEMORAL NAIL ORTHOPEDIC DESIGNS NORTH AMERICA, 510(k) NO: K111352(ABBREVIATED) ATTN: SETH MASEK PHONE NO : 813 443 4905 5912 BRECKENRIDGE PARKWAY SUITE F SE DECISION MADE: 22-AUG-11 TAMPA FL 33610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEKA TAC DEVICE DEKA RESEARCH & DEVELOPMENT CORP. 510(k) NO: K093915(TRADITIONAL) ATTN: ROBERT SWAIN PHONE NO : 603 669 5139 340 COMMERCIAL ST. SE DECISION MADE: 23-AUG-11 MANCHESTER NH 03101 1108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DDRELEMENT SWISSRAY MEDICAL AG 510(k) NO: K110828(TRADITIONAL) ATTN: JOHN MONAHAN PHONE NO : 908 372 6412 ONE TOWER CENTER SE DECISION MADE: 23-AUG-11 EAST BRUNSWICK NJ 07201 510(k) STATEMENT DEVICE: BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL BIO-RAD LABORATORIES 510(k) NO: K111072(SPECIAL) ATTN: JUANG WANG PHONE NO : 510 741 4609 5500 E. 2ND STREET SE DECISION MADE: 23-AUG-11 BENICIA CA 94510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESPIRE BLUE SERIES RESPIRE MEDICAL 510(k) NO: K111207(ABBREVIATED) ATTN: DANIELA LEVY PHONE NO : 213 447 5297 22817 VENTURA BLVD #161 SE DECISION MADE: 23-AUG-11 WOODLAND HILLS CA 91364 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) RONGYAO PLASTIC PRODUCE CO., LTD 510(k) NO: K110016(TRADITIONAL) ATTN: ZHAO GANG PHONE NO : 863 182 126583 #58 BINHU ROAD SE DECISION MADE: 23-AUG-11 HENGSHUICITY CH 053000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRA(TM) CUSA NXT(TM) BONE TIPS INTEGRA BURLINGTON MA, INC. (FORME510(k) NO: K111741(TRADITIONAL) ATTN: KEVIN J O'CONNELL PHONE NO : 781 565 1227 22 Terry Ave SE DECISION MADE: 23-AUG-11 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS SKELETAL DYNAMICS, LLC 510(k) NO: K111620(TRADITIONAL) ATTN: ANA M ESCAGEDO PHONE NO : 305 596 7585 8905 SW 87 AVENUE, SUITE 201 SE DECISION MADE: 23-AUG-11 MIAMI FL 33176 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PR510(k) NO: K111507(TRADITIONAL) ATTN: CAPT HYE-JOO KIM, PHARM.D. PHONE NO : 404 639 4643 1600 CLIFTON RD. MS-C12 SE DECISION MADE: 23-AUG-11 ATLANTA GA 30333 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG DERMA CARE PLUS PRODUCTS, LLC 510(k) NO: K111589(TRADITIONAL) ATTN: JOSEPH NEUSER PHONE NO : 920 469 4514 2614 MAIN STREET SE DECISION MADE: 23-AUG-11 GREEN BAY WI 54311 510(k) STATEMENT DEVICE: PASS ANTERIOR SPINAL SYSTEM MEDICREA TECHNOLOGIES 510(k) NO: K102406(TRADITIONAL) ATTN: J D WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD. SE DECISION MADE: 23-AUG-11 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STREAMLINE TL SPINAL SYSTEM PIONEER SURGICAL TECHNOLOGY, INC 510(k) NO: K111502(TRADITIONAL) ATTN: SARAH MCINTYRE PHONE NO : 906 225 5861 375 RIVER PARK CIRCLE SE DECISION MADE: 23-AUG-11 Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE CIRCLE CARDIOVASCULAR IMAGING INC.510(k) NO: K111373(TRADITIONAL) ATTN: SHIRANTHA SAMARAPPULI PHONE NO : 403 338 1870 #12, 3535 RESEARCH ROAD NW SE DECISION MADE: 23-AUG-11 CALGARY, AB CA T2L 2K8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR APPLIED CARDIAC SYSTEMS, INC. 510(k) NO: K103706(ABBREVIATED) ATTN: R. BEN GHADIMI PHONE NO : 949 855 9366 22912 EL PACIFICO DRIVE SE DECISION MADE: 24-AUG-11 LAGUNA HILLS CA 92653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFECARE CONDUCTIVE GARMENTS EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K103719(ABBREVIATED) ATTN: JAY MANSOUR PHONE NO : 678 908 8180 845 ARONSON LAKE COURT SE DECISION MADE: 24-AUG-11 ROSWELL GA 30075 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM INSTRUMENTATION LABORATORY CO. 510(k) NO: K110031(TRADITIONAL) ATTN: JACQUELINE EMERY PHONE NO : 781 861 4350 180 HARTWELL ROAD SE DECISION MADE: 24-AUG-11 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT C.R. BARD, INC. 510(k) NO: K102511(TRADITIONAL) ATTN: JONI CREAL PHONE NO : 480 638 2906 1625 WEST 3RD ST. SE DECISION MADE: 24-AUG-11 TEMPE AZ 85281 1740 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL THERMOMETER MT SERIES SEJOY ELECTRONICS & INSTRUMENTS CO510(k) NO: K110776(SPECIAL) ATTN: YUNHUA REN PHONE NO : 865 718 1957767 WEST LAKE ECONOMY & TECHNOLOGY ZONSE DECISION MADE: 24-AUG-11 HANGZHOU, ZHEJIANG CH 310030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM SOUNDCURE INC 510(k) NO: K111293(TRADITIONAL) ATTN: NANCY LINCE PHONE NO : 650 759 6186 560 SOUTH WINCHESTER BLVD SUITE 50SE DECISION MADE: 24-AUG-11 SAN JOSE CA 95128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHENGKUN CHEMICAL ZIBO SHENGKUN CHEMICAL INDUSTRIAL 510(k) NO: K110621(TRADITIONAL) ATTN: JASON LIU PHONE NO : 865 337 524868 FINE CHEMICAL PARK, CHEMICAL INDUSSE DECISION MADE: 24-AUG-11 ZIBO, SHANDONG CH 255400 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIMETER INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK 510(k) NO: K111525(SPECIAL) ATTN: MIKE SCOTT PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 24-AUG-11 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHESAPEAKE (CERVICAL COMPONENTS) K2M, INC. 510(k) NO: K111439(TRADITIONAL) ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR.,SE SE DECISION MADE: 24-AUG-11 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOGEL ORTHOPOR BROWN SURGICAL GLOVE MOLNLYCKE HEALTHCARE, US LLC 510(k) NO: K112089(SPECIAL) ATTN: ANGELA L BUNN, RAC PHONE NO : 678 250 7930 5550 PEACHTREE PARKWAY SUITE 500 SE DECISION MADE: 24-AUG-11 NORCROSS GA 30092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECG SERIES ELECTROCARDIOGRAPH ADVANCED INSTRUMENTATIONS, INC. 510(k) NO: K111805(TRADITIONAL) ATTN: JORGE MILLAN PHONE NO : 305 925 1260 601 W 20 ST SE DECISION MADE: 24-AUG-11 HIALEAH FL 33010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVANT, MOBILE CARDIAC TELEMETRY CORVENTIS, INC. 510(k) NO: K111917(ABBREVIATED) ATTN: MICHELE CHIN-PURCELL PHONE NO : 651 925 3803 1410 ENERGY PARK DRIVE, SUITE 1 SE DECISION MADE: 24-AUG-11 ST. PAUL MN 55108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES PIONEER SURGICAL TECHNOLOGY, INC 510(k) NO: K111528(SPECIAL) ATTN: SARAH MCINTYRE PHONE NO : 906 225 5861 375 RIVER PARK CIRCLE SE DECISION MADE: 24-AUG-11 Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VESOFLOW CAREMED SUPPLY, INC. 510(k) NO: K110977(TRADITIONAL) ATTN: EDWARD A KROLL PHONE NO : 440 546 9810 5905 FAWN LANE SE DECISION MADE: 25-AUG-11 CLEVELAND OH 44141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DAYTONA ANTERIOR CERVICAL CAGE SPINENET, LLC 510(k) NO: K110733(TRADITIONAL) ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD SE DECISION MADE: 25-AUG-11 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEMORE MUSCLE CONDITIONER; GEMORE TECHNOLOGY CO., LTD. 510(k) NO: K102926(TRADITIONAL) ATTN: BODEN LAI PHONE NO : 886 288 091799 11 FL, NO. 29-5, SEC. 2 CHUNG CHENSE DECISION MADE: 25-AUG-11 TAN SHUI, TAIPEI HSIEN TW 251 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K110934(TRADITIONAL) ATTN: SANDRA D WHITE PHONE NO : 508 660 4553 333 CONEY STREET SE DECISION MADE: 25-AUG-11 WALPOLE MA 02032 1516 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS N-MID OSTEOCALCIN CALCHECK 5 ROCHE DIAGNOSTICS 510(k) NO: K112104(TRADITIONAL) ATTN: JANE E PHILLIPS PHONE NO : 317 521 3338 9115 HAGUE ROAD SE DECISION MADE: 25-AUG-11 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS SENTINEL MEDICAL, INC. 510(k) NO: K112112(SPECIAL) ATTN: JOAN MEDLEY PHONE NO : 647 258 3607 555 RICHMOND STREET WEST SUITE 800SE DECISION MADE: 25-AUG-11 TORONTO CA M5V 3B1 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONICATOR PLUS 920 METTLER ELECTRONICS CORP. 510(k) NO: K111482(SPECIAL) ATTN: CHRISTINA CAYUELA PHONE NO : 714 533 2221 1333 SOUTH CLAUDINA ST. SE DECISION MADE: 25-AUG-11 ANAHEIM CA 92805 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: YOULASER CO2 LASER SYSTEM QUANTA SYSTEM, S.P.A. 510(k) NO: K111592(TRADITIONAL) ATTN: MAURIZIO BIANCHI PHONE NO : 39 033 1376797 VIA IV NOVEMBRE,116 SE DECISION MADE: 25-AUG-11 SOLBIATE OLONA(VA) IT 21058 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: XYLOS MACRO-POROUS SURGICAL MESH XYLOS CORPORATION 510(k) NO: K111584(TRADITIONAL) ATTN: GONZALO C SERAFICA PHONE NO : 215 867 0220 838 TOWN CENTER DR. SE DECISION MADE: 25-AUG-11 LANGHORNE PA 19047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUILION LB MOVEMENT BASE KIT TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K111633(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714 669 7808 2441 MICHELLE DR SE DECISION MADE: 25-AUG-11 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC. 510(k) NO: K101234(TRADITIONAL) ATTN: JUDY HOWE PHONE NO : 520 229 3829 1910 EAST INNOVATION PARK DR. SE DECISION MADE: 25-AUG-11 TUCSON AZ 85755 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET NORFOLK MEDICAL 510(k) NO: K111101(TRADITIONAL) ATTN: MICHAEL J DALTON PHONE NO : 847 674 7075 7350 N. RIDGEWAY SE DECISION MADE: 25-AUG-11 SKOKIE IL 60076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOWRIST ONE SUCTION/IRRIGATOR INTUITIVE SURGICAL, INC. 510(k) NO: K110451(TRADITIONAL) ATTN: BRANDON HANSEN PHONE NO : 408 523 2100 1266 KIFER ROAD SE DECISION MADE: 26-AUG-11 SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTINCT JAVA SYSTEM ZIMMER SPINE 510(k) NO: K111301(TRADITIONAL) ATTN: ELSA A LINKE PHONE NO : 952 830 6205 7375 BUSH LAKE ROAD SE DECISION MADE: 26-AUG-11 EDINA MN 55439 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL WELL LEAD MEDICAL CO. LTD 510(k) NO: K110269(TRADITIONAL) ATTN: JOHN OBRIEN PHONE NO : 813 645 2855 962 ALLEGRO LANE SE DECISION MADE: 26-AUG-11 APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COVAMAX RESORBABLE COLLAGEN MEMBRANE BIOM'UP SAS 510(k) NO: K103087(TRADITIONAL) ATTN: VALERIE CENTIS PHONE NO : 330 486 573610 8, ALLEE IRENE JOLIOT-CURIE SE DECISION MADE: 26-AUG-11 ST-PRIEST FR 69800 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS ANDON MEDICAL CO., LTD. 510(k) NO: K102678(TRADITIONAL) ATTN: YI LIU PHONE NO : 862 287 612426 NO. 04-23-3 AIRPORT INDUSTRIAL PARSE DECISION MADE: 26-AUG-11 TIANJIN CH 300381 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONOBLOC BM SERIES HASS CORP. 510(k) NO: K111573(TRADITIONAL) ATTN: PRISCILLA CHUNG PHONE NO : 714 869 3080 951 STARBUCK ST. UNIT J SE DECISION MADE: 26-AUG-11 FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING AIRSTRIP TECHNOLOGIES, LP 510(k) NO: K112235(TRADITIONAL) ATTN: ANDY MILLER PHONE NO : 210 363 8753 3303 OAKWELL CT., SUITE 200 SE DECISION MADE: 26-AUG-11 SAN ANTONIO TX 78218 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM GENORAY CO., LTD. 510(k) NO: K103181(TRADITIONAL) ATTN: JAE KIM PHONE NO : 714 289 8020 1073 N, BATAVIA ST SE DECISION MADE: 26-AUG-11 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER EXACT MEDICAL MANUFACTURING, INC 510(k) NO: K111535(TRADITIONAL) ATTN: ROBERT O DEAN PHONE NO : 716 440 7362 1083 DELAWARE AVE SE DECISION MADE: 26-AUG-11 BUFFALO NY 14209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIOSCULPT PTA SCORING BALLOON CATHETER ANGIOSCORE, INC. 510(k) NO: K112182(SPECIAL) ATTN: JONATHAN S KAHAN PHONE NO : 202 637 5794 555 THIRTEENTH STREET NW SE DECISION MADE: 26-AUG-11 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMFORTGLIDE INTERMITENT CATHETER C.R. BARD, INC. 510(k) NO: K112137(TRADITIONAL) ATTN: STACCI CRONK PHONE NO : 770 784 6994 8195 INDUSTRIAL BLVD. SE DECISION MADE: 26-AUG-11 COVINGTON GA 30014 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AUTOREADER 2 TREK DIAGNOSTIC SYSTEMS 510(k) NO: K103532(TRADITIONAL) ATTN: CYNTHIA KNAPP PHONE NO : 216 351 8735 982 KEYNOTE CIRCLE SE DECISION MADE: 26-AUG-11 CLEVELAND OH 44131 510(k) STATEMENT DEVICE: HARMONIE SYSTEM STELLATE SYSTEMS 510(k) NO: K083577(ABBREVIATED) ATTN: GOLDY SINGH PHONE NO : 905 829 5300 376 VICTORIA AVENUE, SUITE 200 SE DECISION MADE: 29-AUG-11 MONTREAL, QUEBEC CA H3Z 1C3 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020 ABBOTT MOLECULAR, INC. 510(k) NO: K091960(TRADITIONAL) ATTN: PAMELA L SWATKOWSKI PHONE NO : 224 361 7013 1300 EAST TOUHY AVENUE SE DECISION MADE: 29-AUG-11 DES PLAINES IL 60018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INQU PASTE MIX PLUS ISTO TECHNOLOGIES, INC. 510(k) NO: K103799(TRADITIONAL) ATTN: PATSY J TRISLER, JD, RAC PHONE NO : 301 652 6344 5600 WISCONSIN AVE. #509 SE DECISION MADE: 29-AUG-11 CHEVY CHASE MD 20815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES DAAVLIN DISTRIBUTING CO. 510(k) NO: K111172(TRADITIONAL) ATTN: MICHELE THIEL PHONE NO : 419 636 6304 205 WEST BEMENT ST. SE DECISION MADE: 29-AUG-11 BRYAN OH 43506 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLUEPHASE STYLE IVOCLAR VIVADENT, INC. 510(k) NO: K110756(TRADITIONAL) ATTN: DONNA MARIE HARTNETT PHONE NO : 716 691 2260 175 PINEVIEW DR. SE DECISION MADE: 29-AUG-11 AMHERST NY 14228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM NOVA BIOMEDICAL CORPORATION 510(k) NO: K110648(SPECIAL) ATTN: PAUL W MACDONALD PHONE NO : 781 894 0800 200 PROSPECT ST. SE DECISION MADE: 29-AUG-11 WALTHAM MA 02453 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K103308(SPECIAL) ATTN: CRYSTAL DIZOL HAGAN PHONE NO : 424 218 8381 2151 E. GRAND AVE. SE DECISION MADE: 29-AUG-11 EL SEGUNDO CA 90245 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLIC SCREW REPAIR SYSTEM ACUMED LLC 510(k) NO: K111608(SPECIAL) ATTN: HOLLACE RHODES PHONE NO : 202 552 5800 1331 H STREET NW 12TH FLOOR SE DECISION MADE: 29-AUG-11 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MATRISTEM WOUND MATRIX ACELL, INC 510(k) NO: K112409(SPECIAL) ATTN: DEBORAH A BAKER-JANIS PHONE NO : 410 715 1700 6640 ELI WHITNEY DRIVE SUITE 200 SE DECISION MADE: 29-AUG-11 COLUMBIA MD 21046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL SERF 510(k) NO: K111572(TRADITIONAL) ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD. SE DECISION MADE: 29-AUG-11 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) SMITHS MEDICAL MD, INC. 510(k) NO: K111386(TRADITIONAL) ATTN: JAMES CHAPMAN PHONE NO : 651 628 7611 1265 GREY FOX RD. SE DECISION MADE: 29-AUG-11 ST. PAUL MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONO-SERIES CORNERSTONE TECHNIQUE PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K111374(TRADITIONAL) ATTN: CHRISTIAN QUASS PHONE NO : 497 704 9291 KARL-HALL-STRASSE 01 SE DECISION MADE: 29-AUG-11 GEISINGEN, BADEN-WURTTEMBERG GM510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM SAMSUNG MEDISON CO., LTD 510(k) NO: K112339(TRADITIONAL) ATTN: KYEONG-MI PARK PHONE NO : 822 219 41373 1003 DAECHI-DONG, GANGNAM-GU SE DECISION MADE: 29-AUG-11 SEOUL KS 135-280 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SNAP WOUND CARE SYSTEM SPIRACUR, INC. 510(k) NO: K112341(SPECIAL) ATTN: SARAH CANIO PHONE NO : 408 400 0856 755 N. MATHILDA AVENUE SE DECISION MADE: 29-AUG-11 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION RIGHTMEDICAL PRODUCTS, LLC 510(k) NO: K110129(TRADITIONAL) ATTN: MELANIE DESLAURIERS PHONE NO : 416 615 0185 1430 BIRCHMOUNT ROAD SE DECISION MADE: 30-AUG-11 TORONTO, ONTARIO CA M1P 2E8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE XIAN FRIENDSHIP MEDICAL ELECTRONIC510(k) NO: K110289(TRADITIONAL) ATTN: ZHAI YING CHUAN PHONE NO : 862 988 225200 NO 9, GAO ZIN 1ST ROAD HI-TECH DEVSE DECISION MADE: 30-AUG-11 XI'AN, SHAANXI CH 710075 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZYTO HAND CRADLE ZYTO TECHNOLOGIES, INC 510(k) NO: K111308(TRADITIONAL) ATTN: VAUGHN R COOK PHONE NO : 801 224 7199 387 SOUTH 520 WEST SUITE 200 SE DECISION MADE: 30-AUG-11 LINDON UT 84042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K111548(TRADITIONAL) ATTN: KATHERINE Y CHOI PHONE NO : 203 602 3568 419 WEST AVE. SE DECISION MADE: 30-AUG-11 STAMFORD CT 06902 6300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY STTUNE (TM) PS KNEE SYSTEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K111433(TRADITIONAL) ATTN: NANCY FRIDDLE PHONE NO : 574 371 4923 700 ORTHOPAEDIC DRIVE SE DECISION MADE: 30-AUG-11 WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 ELITECHGROUP 510(k) NO: K112029(ABBREVIATED) ATTN: DEBRA K HUTSON PHONE NO : 425 482 5174 21720 23RD DR SE SUITE 150 SE DECISION MADE: 30-AUG-11 BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200 TYSON BIORESEARCH, INC. 510(k) NO: K101543(SPECIAL) ATTN: WEN-HAI TSAI PHONE NO : 886 37 585988 5F, #22, KE E. ROAD, III SCIENCE-BSE DECISION MADE: 30-AUG-11 CHUN-NAN, MIAO-LI COUNTY TW 350510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALINDROME RT CHRONIC CATHETER COVIDIEN 510(k) NO: K111817(SPECIAL) ATTN: WING NG PHONE NO : 508 261 6596 15 HAMPSHIRE STREET SE DECISION MADE: 30-AUG-11 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONICA IF24 MONICA HEALTHCARE 510(k) NO: K112163(TRADITIONAL) ATTN: IAN HOW PHONE NO : 44 011 59124541 PENNYFOOT STREET SE DECISION MADE: 30-AUG-11 NOTTINGHAM UK NG1 1GF 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4" (45MM) AND 18GA X 1-1/4" (32MM) / 20GA X 1-1/4" (32MM) / 20GA X 1 B. BRAUN MELSUNGEN AG 510(k) NO: K111236(TRADITIONAL) ATTN: ANGELA J CARAVELLA PHONE NO : 610 596 2966 901 MARCON BLVD SE DECISION MADE: 30-AUG-11 ALLENTOWN PA 18109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TSRH SPINAL SYSTEMS MEDTRONIC SOFAMOR DANEK USA, INC 510(k) NO: K111942(SPECIAL) ATTN: LILA JOE PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 30-AUG-11 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K101635(TRADITIONAL) ATTN: TELING HSU PHONE NO : 886 266 258188 3F,5F, NO.127 WUGONG 2ND RD, WUGU SE DECISION MADE: 31-AUG-11 TAIPEI COUNTY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION APEX BIOTECHNOLOGY CORP. 510(k) NO: K101204(TRADITIONAL) ATTN: HSUE-MEI LEE PHONE NO : 886 356 41952 NO. 7, LI-HSIN ROAD V, HSINCHU SCISE DECISION MADE: 31-AUG-11 HSINCHU TW 30078 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CMC CABLE FIX INSTRATEK, INC. 510(k) NO: K111032(TRADITIONAL) ATTN: JEFF SEAVEY PHONE NO : 281 890 9020 4141 DIRECTORS ROW SUITE H SE DECISION MADE: 31-AUG-11 HOUSTON TX 77092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS ELITECHGROUP SEPPIM S.A.S. 510(k) NO: K103747(TRADITIONAL) ATTN: DEBRA K HUTSON PHONE NO : 425 482 5174 21720 23RD DR SE, SUITE 150 SE DECISION MADE: 31-AUG-11 BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MORPHEUS OX DEGANIT BARAK-SHINAR 510(k) NO: K111314(TRADITIONAL) ATTN: JOHN SMITH PHONE NO : 202 637 5600 555 THIRTEENTH STREET, NW SE DECISION MADE: 31-AUG-11 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPSURE(R) PS SYSTEM SPINE WAVE, INC. 510(k) NO: K111913(SPECIAL) ATTN: ROAIDA RIZKALLAH PHONE NO : 203 944 9494 THREE ENTERPRISE DR SUITE 210 SE DECISION MADE: 31-AUG-11 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STEERABLE GUIDE CATHETER ABBOTT VASCULAR 510(k) NO: K112239(SPECIAL) ATTN: CYNTHIA MORROW PHONE NO : 650 833 1610 4045 CAMPBELL AVE SE DECISION MADE: 31-AUG-11 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM CIRCA SCIENTIFIC, LLC 510(k) NO: K112376(TRADITIONAL) ATTN: FRED PIAZZA PHONE NO : 303 951 8767 14 INVERNESS DRIVE EAST, SUITE H24SE DECISION MADE: 31-AUG-11 ENGLEWOOD CO 80112 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MDRIVE EMBLA SYSTEMS 510(k) NO: K111742(SPECIAL) ATTN: ROBERT G SCHUEPPERT PHONE NO : 303 962 1786 9351 GRANT STREET SUITE 600 SE DECISION MADE: 31-AUG-11 THORNTON CO 80229 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 271 TOTAL WITH SUMMARIES 257 TOTAL WITH STATEMENTS 14
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