510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD June 2011
DEVICE: INVADER FACTOR V
HOLOGIC, INC. 510(k) NO: K100980(TRADITIONAL)
ATTN: RANDALL J COVILL PHONE NO : 508 263 8853
250 CAMPUS DRIVE SE DECISION MADE: 01-JUN-11
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONNEX VITAL SIGNS MONITOR 6000 SERIES
WELCH ALLYN, INC. 510(k) NO: K110516(SPECIAL)
ATTN: FRED SCHWEITZER PHONE NO : 315 554 4001
4341 STATE ST. RD. P.O. BOX 220 SE DECISION MADE: 01-JUN-11
SKANEATELES FALLS NY 13153 0220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JETSTREAM G3 (R) SF 1.6 SYSTEM
PATHWAY MEDICAL TECHNOLOGIES, INC.510(k) NO: K111229(SPECIAL)
ATTN: CYNDY ADAMS PHONE NO : 425 636 4047
10801 120TH AVENUE NE SE DECISION MADE: 01-JUN-11
KIRKLAND WA 98033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIS ANTERIOR CERVICAL PLATING SYSTEM
LIFE SPINE 510(k) NO: K103423(TRADITIONAL)
ATTN: RANDY LEWIS PHONE NO : 847 884 6117
2401 W. HASSELL RD. SUITE 1535 SE DECISION MADE: 01-JUN-11
HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: H-WAVE
ELECTRONIC WAVEFORM LABORATORY, IN510(k) NO: K103738(SPECIAL)
ATTN: RYAN P HEANEY PHONE NO : 800 874 9283
16168 BEACH BLVD., SUITE 232 SE DECISION MADE: 01-JUN-11
HUNTINGTON BEACH CA 92647 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIT, PHACOFRAGMENTATION
ABBOTT MEDICAL OPTICS INC 510(k) NO: K103023(ABBREVIATED)
ATTN: EVELYN DE LA VEGA PHONE NO : 714 247 8487
1700 E. ST. ANDREW PLACE SE DECISION MADE: 01-JUN-11
SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS
RESPIRONICS, INC. 510(k) NO: K110398(ABBREVIATED)
ATTN: JOSEPH E OLSAVSKY PHONE NO : 724 387 7562
1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 01-JUN-11
MONROEVILLE PA 15146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVADER FACTOR II
HOLOGIC, INC. 510(k) NO: K100943(TRADITIONAL)
ATTN: RANDALL COVILL PHONE NO : 508 263 8853
250 CAMPUS DRIVE SE DECISION MADE: 02-JUN-11
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WATCH-PAT 200S-3 (WP200S-3)
ITAMAR MEDICAL LTD 510(k) NO: K102567(TRADITIONAL)
ATTN: JONATHAN KAHN PHONE NO : 202 637 5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 02-JUN-11
WASHINGTON DC 20004 1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER
ABBOTT VASCULAR 510(k) NO: K110617(TRADITIONAL)
ATTN: SUZANNE REDMAN PHONE NO : 951 914 3243
26531 YNEZ ROAD SE DECISION MADE: 02-JUN-11
TEMECULA CA 92591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALARA T210 COMPUTED RADIOGRAPHY SYSTEM
ALARA, INC. 510(k) NO: K102479(TRADITIONAL)
ATTN: CHRISTOPHER MITCHELL PHONE NO : 510 315 5200
47505 SEABRIDGE DRIVE SE DECISION MADE: 02-JUN-11
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AOS ORION IR-192 SOURCE CABLE
ALPHA-OMEGA SERVICES, INC. 510(k) NO: K102811(TRADITIONAL)
ATTN: BOB A ROBNETT PHONE NO : 562 804 0604
9156 ROSE ST SE DECISION MADE: 02-JUN-11
BELLFLOWER CA 90706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAMPAX C PLASTIC TAMPONS, UNSCENTED
THE PROCTER & GAMBLE CO. 510(k) NO: K110669(SPECIAL)
ATTN: KATHLEEN BLIESZNER PHONE NO : 513 634 3168
6110 CENTER HILL AVE. SE DECISION MADE: 02-JUN-11
CINCINNATI OH 45224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HET BIPOLAR ELECTROCAUTERY FORCEPS
HET SYSTEMS, LLC 510(k) NO: K110143(TRADITIONAL)
ATTN: HOWARD L SCHRAYER PHONE NO : 609 924 9510
1502 E 14TH STREET SUITE 2 SE DECISION MADE: 02-JUN-11
BROOKLYN NY 11230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APTUS CANNULATED COMPRESSION SCREWS
MEDARTIS AG 510(k) NO: K110658(TRADITIONAL)
ATTN: KEVIN A THOMAS PHONE NO : 858 792 1235
11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 02-JUN-11
SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST
RESPIRONICS NOVAMETRIX, LLC 510(k) NO: K103578(TRADITIONAL)
ATTN: KEVIN MADER PHONE NO : 203 697 6466
5 TECHNOLOGY DRIVE SE DECISION MADE: 02-JUN-11
WALLINGFORD CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORNIER INSITE FT SUTURE ANCHOR
TORNIER, INC. 510(k) NO: K110773(TRADITIONAL)
ATTN: BRAHIM HADRI PHONE NO : 978 232 9997
100 CUMMINGS CENTER, SUITE 444C SE DECISION MADE: 02-JUN-11
BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYLABGOLD
ESAOTE 510(k) NO: K110688(TRADITIONAL)
ATTN: ALLISON SCOTT PHONE NO : 317 569 9500
11460 N. MERIDIAN ST., STE. 150 SE DECISION MADE: 02-JUN-11
CARMEL IN 46032 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM
ALPHATEC SPINE, INC. 510(k) NO: K103205(TRADITIONAL)
ATTN: OLGA LEWIS PHONE NO : 760 494 6717
2051 PALOMAR AIRPORT ROAD SUITE 10SE DECISION MADE: 02-JUN-11
CARLSBAD CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K103548(ABBREVIATED)
ATTN: SANDRA D WHITE PHONE NO : 508 660 4553
333 CONEY STREET SE DECISION MADE: 02-JUN-11
EAST WALPOLE MA 02032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F
BOSTON SCIENTIFIC CORP. 510(k) NO: K111252(SPECIAL)
ATTN: HOLLY RAMIREZ PHONE NO : 763 494 2113
ONE SCIMED PLACE SE DECISION MADE: 02-JUN-11
MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNI II PATIENT MONITOR
INFINIUM MEDICAL 510(k) NO: K103737(SPECIAL)
ATTN: JOHN OBRIEN PHONE NO : 813 645 2855
962 ALLEGRO LN. SE DECISION MADE: 02-JUN-11
APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REGUIS SIGMA
KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K103703(TRADITIONAL)
ATTN: RUSSELL MUNVES PHONE NO : 212 497 8208
140 EAST 45TH ST., 25TH FLOOR TWO SE DECISION MADE: 02-JUN-11
NEW YORK NY 10017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IGX PLEX CELIAC QUALITATIVE ASSAY
SQI DIAGNOSTICS SYSTEMS 510(k) NO: K102490(TRADITIONAL)
ATTN: KATE SMITH PHONE NO : 416 674 9500
36 METEOR DR. SE DECISION MADE: 02-JUN-11
TORONTO, ONTARIO CA M9W 1A4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRACTORA
INVASIX LTD. 510(k) NO: K102461(TRADITIONAL)
ATTN: AMIR WALDMAN PHONE NO : 972 547 404616
APOLO BUILDING POB 533 SE DECISION MADE: 02-JUN-11
YOKNEAM ILLIT IS 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)...
COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K111442(SPECIAL)
ATTN: ROBERT ZOTT PHONE NO : 203 492 6013
60 Middletown Ave SE DECISION MADE: 03-JUN-11
North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISCOVERY NM 630
GE HEALTHCARE 510(k) NO: K111445(TRADITIONAL)
ATTN: TAL BRESLER-STRAMER PHONE NO : 972 485 63666
4 HAYOZMA STREET SE DECISION MADE: 03-JUN-11
TIRAT HACARMEL IS 30200 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CARDIO XP
BIONET CO., LTD. 510(k) NO: K102767(TRADITIONAL)
ATTN: MARC GOODMAN PHONE NO : 714 258 4646
5405 ALTON PARKWAY, SUITE A530 SE DECISION MADE: 03-JUN-11
IRVINE CA 92604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPLAN
BRAINLAB AG 510(k) NO: K101627(TRADITIONAL)
ATTN: ALEXANDER SCHWIERSCH PHONE NO : 49 89 9915680
KAPELLENSTRASSE 12 SE DECISION MADE: 03-JUN-11
FELDKIRCHEN GM 85622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OWL CANNULAE
DIROS TECHNOLOGY, INC. 510(k) NO: K102566(TRADITIONAL)
ATTN: GEORGE DARMOS PHONE NO : 905 415 3440
232 HOOD ROAD SE DECISION MADE: 03-JUN-11
MARKHAM, ONTARIO CA L3R 3K8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUGLUE-10
3M ESPE AG 510(k) NO: K110508(TRADITIONAL)
ATTN: DESI W SOEGIARTO PHONE NO : 498 152 7001169
ESPE PLATZ SE DECISION MADE: 03-JUN-11
SEEFELD, BAVARIA GM D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40
BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K102614(TRADITIONAL)
ATTN: ANNE-MARIE KEENAN PHONE NO : 353 917 74316
BMR HOUSE PARKMORE BUSINESS PARK, SE DECISION MADE: 03-JUN-11
GALWAY EI EI 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR
SONOSITE,INC. 510(k) NO: K110645(TRADITIONAL)
ATTN: JESSICA R STENBERG PHONE NO : 425 951 1432
21919 30TH DRIVE SE. SE DECISION MADE: 03-JUN-11
BOTHELL WA 98021 3904 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EMULSION SB
PRUGEN IP HOLDINGS, INC 510(k) NO: K110732(TRADITIONAL)
ATTN: ROBERT L KNECHTEL PHONE NO : 480 585 0122
8711 E PINNACLE PEAK ROAD SUITE C-SE DECISION MADE: 03-JUN-11
SCOTTSDALE AZ 85255 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSCO WARMING CABINET
STERIS CORPORATION 510(k) NO: K110769(SPECIAL)
ATTN: ROBERT F SULLIVAN PHONE NO : 440 392 7695
5960 HEISLEY SE DECISION MADE: 03-JUN-11
MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BILLY BOY MALE LATEX CONDOM
MAPA GMBH 510(k) NO: K111093(TRADITIONAL)
ATTN: GERMAN FRANK PHONE NO : 494 281 730213
INDUSTRIESTRASSE 21-25 SE DECISION MADE: 03-JUN-11
ZEVEN GM 27404 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ACE STAPLER AND CARTRIDGE
BAROSENSE, INC 510(k) NO: K110829(SPECIAL)
ATTN: SHEILA STEVENS, PHD PHONE NO : 650 362 6000
250 CHESAPEAKE DRIVE SE DECISION MADE: 03-JUN-11
REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISTAND
OPTOVUE, INC. 510(k) NO: K103266(TRADITIONAL)
ATTN: JOHN J TALARICO PHONE NO : 510 623 8868
45531 NORTHPORT LOOP W. SE DECISION MADE: 03-JUN-11
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMINOS AGILE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K111292(SPECIAL)
ATTN: PATRICIA D JONES PHONE NO : 610 484 3536
51 VALLEY STREAM PKWY. SE DECISION MADE: 03-JUN-11
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHO EASY PIN
FORESTADENT BERNHARD FORSTER GMBH 510(k) NO: K110275(TRADITIONAL)
ATTN: TANYA O'BRIEN PHONE NO : 813 645 2855
962 ALLEGRO LANE SE DECISION MADE: 03-JUN-11
APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K103210(TRADITIONAL)
ATTN: NANCY CHU PHONE NO : 949 453 6435
33 TECHNOLOGY DR. SE DECISION MADE: 06-JUN-11
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
PPP MEDICAL AND SAFETY PRODUCTS CO510(k) NO: K110972(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
ROOM 1606 BUILDING 1 JIAN XIAN YUASE DECISION MADE: 06-JUN-11
RD. HAI DI, BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARTEMP
ULTRADENT PRODUCTS, INC. 510(k) NO: K111017(TRADITIONAL)
ATTN: DIANE ROGERS PHONE NO : 801 553 4491
505 WEST 10200 SOUTH SE DECISION MADE: 06-JUN-11
SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEHIND EAR GENTLE TOUCH THERMOMETER
KAZ, INC. 510(k) NO: K103839(ABBREVIATED)
ATTN: RAJ S KASBEKAR PHONE NO : 508 490 7280
250 TURNPIKE ROD SE DECISION MADE: 06-JUN-11
SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE
TERUMO EUROPE N.V. 510(k) NO: K110527(TRADITIONAL)
ATTN: M. J AERTS PHONE NO : 32 016 381211
INTERLEUVENLAAN 40 SE DECISION MADE: 06-JUN-11
LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM
DENTSPLY INTERNATIONAL, INC. 510(k) NO: K110753(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717 849 4229
221 WEST PHILADELPHIA ST. SUITE 60SE DECISION MADE: 06-JUN-11
YORK PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUE POWDERFREE NITRILE EXAMINATION GLOVE
PT. MEDISAFE TECHNOLOGIES 510(k) NO: K102623(TRADITIONAL)
ATTN: ANIL TANEJA PHONE NO : 626 130 007134
JL.BATANG KUIS GG.TAMBAK REJO DESASE DECISION MADE: 06-JUN-11
MEDAN, NORTH SUMATERA ID 20362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
SAC, LLC DBA PINNACLE MEDICAL SURG510(k) NO: K101733(TRADITIONAL)
ATTN: DAVE STRAIN PHONE NO : 407 745 1027
P.O. BOX 782108 SE DECISION MADE: 06-JUN-11
ORLANDO FL 32878 2108 510(k) STATEMENT
DEVICE: MINI VARIABLE SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K111041(SPECIAL)
ATTN: DEREK LEWIS PHONE NO : 330 869 9562
1065 MEDINA ROAD SUITE 500 SE DECISION MADE: 06-JUN-11
MEDINA OH 44256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUBLUE NASAL MASK
RESPIRONICS, INC. 510(k) NO: K110405(SPECIAL)
ATTN: MICHELLE BRINKER PHONE NO : 724 387 4146
1001 MURRY RIDGE LN. SE DECISION MADE: 06-JUN-11
MURRYSVILLE PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC
DYNAREX CORPORATION 510(k) NO: K103086(TRADITIONAL)
ATTN: DANIEL CONSAGA PHONE NO : 845 365 8200
10 GLENSHAW ST. SE DECISION MADE: 07-JUN-11
ORANGEBURG NY 10962 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILLUMINATING SINUS SEEKER
ENTELLUS MEDICAL, INC. 510(k) NO: K110158(TRADITIONAL)
ATTN: KAREN E PETERSON PHONE NO : 763 463 7056
6705 WEDGWOOD COURT NORTH SE DECISION MADE: 07-JUN-11
MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG
CARDINAL HEALTH, INC. 510(k) NO: K110272(TRADITIONAL)
ATTN: TATYANA BOGDAN PHONE NO : 847 887 2325
1430 WAUKEGAN ROAD SE DECISION MADE: 08-JUN-11
MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA
BUSSE HOSPITAL DISPOSABLES 510(k) NO: K110883(TRADITIONAL)
ATTN: MUHAMAD ANSARI PHONE NO : 631 435 4711
75 ARKAY DRIVE SE DECISION MADE: 08-JUN-11
HAUPPAUGE NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE
MIDWEST REPROCESSING CENTER LLC 510(k) NO: K111007(TRADITIONAL)
ATTN: SCOTT SENNER PHONE NO : 205 314 3920
434 INDUSTRIAL LANE SE DECISION MADE: 08-JUN-11
BIRMINGHAM AL 35211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 10 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030)
EIZO GMBH 510(k) NO: K103724(ABBREVIATED)
ATTN: GUENTER M VOLZ PHONE NO : 49 721 20321282
SIEMENSALLEE 84 SE DECISION MADE: 08-JUN-11
KARLSRUHE GM 76187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PACEART OPTIMA SYSTEM SOFTWARE
MEDTRONIC, INC. 510(k) NO: K110693(TRADITIONAL)
ATTN: RACHEL U LIBI PHONE NO : 763 526 1668
8200 CORAL SEA STREET SE DECISION MADE: 08-JUN-11
MOUNDS VIEW MN 55304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO
ETHICON ENDO-SURGERY, LLC 510(k) NO: K111111(TRADITIONAL)
ATTN: LINDA HILL PHONE NO : 513 337 7623
4545 CREEK ROAD SE DECISION MADE: 08-JUN-11
CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMESH TACKER
EASYLAP LTD. 510(k) NO: K110728(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
24301 WOODSAGE DRIVE SE DECISION MADE: 08-JUN-11
BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM
MEDYSSEY CO., LTD. 510(k) NO: K110284(SPECIAL)
ATTN: PATRICK MOORE PHONE NO : 801 266 4811
6170 SOUTH 380 WEST SUITE 200 SE DECISION MADE: 08-JUN-11
MURRAY UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIPURPOSE DRAINAGE CATHETER
NAVILYST MEDICAL, INC. 510(k) NO: K111315(SPECIAL)
ATTN: WANDA CARPINELLA PHONE NO : 508 658 7929
26 FOREST STREET SE DECISION MADE: 08-JUN-11
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANCK USA, INC. 510(k) NO: K110070(TRADITIONAL)
ATTN: LILA JOE PHONE NO : 901 396 3133
1800 PYRAMID PLACE SE DECISION MADE: 08-JUN-11
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT
EXACTECH, INC. 510(k) NO: K111379(SPECIAL)
ATTN: GRAHAM L CUTHBERT PHONE NO : 352 377 1140
2320 N.W. 66TH CT. SE DECISION MADE: 08-JUN-11
GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
MEDTRONIC INC. 510(k) NO: K111339(SPECIAL)
ATTN: AMRA RACIC PHONE NO : 763 514 9838
8200 CORAL SEA STREET NE SE DECISION MADE: 08-JUN-11
MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERKA. PERFECT-ANEROID
ERKA KALLMEYER MEDIZINTECHNIK GMBH510(k) NO: K103637(TRADITIONAL)
ATTN: JAN WEISS PHONE NO : 498 041 80090
IM FARCHET 15 SE DECISION MADE: 08-JUN-11
BAD TOELZ, BAVARIA GM 83646 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BIOGRAPH MMR
SIEMENS MEDICAL SOLUTIONS USA INC.510(k) NO: K103429(TRADITIONAL)
ATTN: ALAINE MEDIO PHONE NO : 865 218 2703
810 INNOVATION DRIVE SE DECISION MADE: 08-JUN-11
KNOXVILLE TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEROVENT PLUS CHC
MONAGHAN MEDICAL CORPORATION 510(k) NO: K110273(TRADITIONAL)
ATTN: CARI J REIL PHONE NO : 518 561 7330
5 LATOUR AVENUE, SUITE 1600 SE DECISION MADE: 09-JUN-11
PLATTSBURGH NY 12901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-PACK II NEEDLE- 27G & 30G THIN WALL
TERUMO EUROPE N.V. 510(k) NO: K110850(SPECIAL)
ATTN: M.J. AERTS PHONE NO : 320 163 81211
INTERLEUVENLAAN 40 SE DECISION MADE: 09-JUN-11
LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
VITAL DIAGNOSTICS (MANUFACTURING) 510(k) NO: K110394(ABBREVIATED)
ATTN: MELITA LAMBIRIS PHONE NO : 613 879 36300
189-199 BROWNS RD SE DECISION MADE: 09-JUN-11
NOBLE PARK, VICTORIA AS 3174 510(k) STATEMENT
DEVICE: SAFEPORT MANIFOLD (TM) (OR STOPCOCK)
ELCAM MEDICAL A.C.A.L. 510(k) NO: K111016(SPECIAL)
ATTN: NATASHA EVRONYAN PHONE NO : 972 469 88821
KIBBUTZ BAR-AM SE DECISION MADE: 09-JUN-11
D.N. MEROM HAGALIL IS 13860 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENGAGE/ENGAGE TR INTRODUCERS
ST. JUDE MEDICAL 510(k) NO: K111092(SPECIAL)
ATTN: VENKATA DAMARAJU PHONE NO : 651 756 3259
14901 DEVEAU PL. SE DECISION MADE: 09-JUN-11
MINNETONKA MN 55345 2126 510(k) STATEMENT
DEVICE: ATRICURE DISSECTOR
ATRICURE, INC. 510(k) NO: K111020(SPECIAL)
ATTN: JAMES L LUCKY PHONE NO : 513 755 4100
6217 CENTRE PARK DRIVE SE DECISION MADE: 09-JUN-11
WEST CHESTER OH 45069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KJ MASK
KJ MEDITECH CO., LTD 510(k) NO: K103019(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 869 3080
951 STARBUCK ST. UNIT J SE DECISION MADE: 09-JUN-11
FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS SHBG CALCHECK 5
ROCHE DIAGNOSTICS 510(k) NO: K111349(TRADITIONAL)
ATTN: KELLY FRENCH PHONE NO : 317 521 3208
9115 HAGUE ROAD PO BOX 50416 SE DECISION MADE: 09-JUN-11
INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS
CARDIAC SCIENCE CORPORATION 510(k) NO: K102496(SPECIAL)
ATTN: KATHLEEN ROBERTS PHONE NO : 949 797 3844
3303 MONTE VILLA PKWY. SE DECISION MADE: 09-JUN-11
BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE
DMC MEDICAL LTD. 510(k) NO: K103736(TRADITIONAL)
ATTN: TRACY BEST PHONE NO : 801 498 0067
944 NORTH MAIN STREET SE DECISION MADE: 10-JUN-11
BOUNTIFUL UT 84010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUDIT MICROCV IMMUNOASSAY LINEARITY SET
AALTO SCIENTIFIC LTD. 510(k) NO: K103601(TRADITIONAL)
ATTN: DESSI LYAKOV PHONE NO : 760 431 7922
1959 KELLOGG AVE. SE DECISION MADE: 10-JUN-11
CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESSURE MANOMETER
NEOFORCE GROUP INC 510(k) NO: K110119(TRADITIONAL)
ATTN: MONICA FERRANTE PHONE NO : 215 672 6800
35 COMMERCE DRIVE SE DECISION MADE: 10-JUN-11
IVYLAND PA 18974 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER
CREGANNA-TACTX MEDICAL 510(k) NO: K110133(TRADITIONAL)
ATTN: DENNIS WONG PHONE NO : 408 364 7106
1353 DELL AVENUE SE DECISION MADE: 10-JUN-11
CAMPBELL CA 95008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03
VEGA TECHNOLOGIES, INC. 510(k) NO: K102625(TRADITIONAL)
ATTN: JOSEPH LU PHONE NO : 886 225 416996
11F-13, 100 CHANG-CHUN RD. SE DECISION MADE: 10-JUN-11
TAIPEI TW 104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEFENDO Y-OPSY IRRIGATOR
BYRNE MEDICAL INCORPORATED 510(k) NO: K110088(TRADITIONAL)
ATTN: JOHN WILLIS PHONE NO : 936 521 4240
3150 Pollok Drive SE DECISION MADE: 10-JUN-11
Conroe TX 77303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUSA NXT EXTENDED LENGTH TIP
INTEGRA RADIONICS, INC. 510(k) NO: K102258(TRADITIONAL)
ATTN: KEVIN J O'CONNELL PHONE NO : 781 565 1227
22 TERRY AVENUE SE DECISION MADE: 10-JUN-11
BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS
SHENZHEN ENVISEN INDUSTRY CO. LIMI510(k) NO: K103584(TRADITIONAL)
ATTN: STEPHEN H GORSKI PHONE NO : 262 594 2114
S65 W35739 PIPER ROAD SE DECISION MADE: 10-JUN-11
EAGLE WI 53119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT
ASTRA TECH, INC. 510(k) NO: K110640(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847 560 4406
8944 TAMAROA TERR. SE DECISION MADE: 10-JUN-11
SKOKIE IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
JIANGSU DONGLING PLASTIC & RUBBER 510(k) NO: K110247(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
ROOM 1606 BUILDING 1,JIAN XIAN YUASE DECISION MADE: 10-JUN-11
BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WHITE COLOR
JIANGSU DONGLING PLASTIC & RUBBER 510(k) NO: K110248(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
ROOM 1606 BUILDING 1,JIAN XIAN YUASE DECISION MADE: 10-JUN-11
BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTODELFIA NEONATAL IRT KIT
WALLAC OY, A SUBSIDIARY OF PERKINE510(k) NO: K110274(TRADITIONAL)
ATTN: SUSAN K HAMANN PHONE NO : 781 663 5872
940 WINTER STREET SE DECISION MADE: 10-JUN-11
WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT ARCHITECT LH CALIBRATORS
ABBOTT LABORATORIES 510(k) NO: K111023(TRADITIONAL)
ATTN: JOHN RIZOS PHONE NO : 847 935 1813
100 ABBOTT PARK ROAD DEPT 9V6, AP5SE DECISION MADE: 10-JUN-11
ABBOTT PARK IL 60064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIGATOR APPLICATIONS SUITE
GE HEALTHCARE FINLAND OY 510(k) NO: K102389(SPECIAL)
ATTN: MONICA MORRISON PHONE NO : 608 221 1551
PO BOX 7550 SE DECISION MADE: 10-JUN-11
MADISON WI 53707 7550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
ANGIODYNAMICS, INC. 510(k) NO: K110936(TRADITIONAL)
ATTN: DAVID A GREER PHONE NO : 518 795 1676
14 PLAZA DRIVE SE DECISION MADE: 10-JUN-11
LATHAM NY 12110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPOCEM
DMG USA, INC. 510(k) NO: K110759(ABBREVIATED)
ATTN: PAMELA PAPINEAU PHONE NO : 978 772 3552
5 WHITCOMB AVE. SE DECISION MADE: 10-JUN-11
AYER MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
PPP MEDICAL AND SAFETY PRODUCTS CO510(k) NO: K110969(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441
ROOM 1606 BUILDING 1 JIAN XIAN YUASE DECISION MADE: 10-JUN-11
RD. HAI DI BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)
MEDSHAPE SOLUTIONS, INC 510(k) NO: K111471(SPECIAL)
ATTN: JACK C GRIFFIS, III PHONE NO : 404 249 9155
1575 NORTHSIDE DRIVE NW SUITE 440 SE DECISION MADE: 10-JUN-11
ATLANTA GA 30318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT
ASTRA TECH, INC. 510(k) NO: K110356(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 547 560 4406
8944 TAMAROA TERR. SE DECISION MADE: 10-JUN-11
SKOKIE IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)
INFIMED, INC. 510(k) NO: K111344(SPECIAL)
ATTN: CATHERINE MULCAHY PHONE NO : 315 453 4545
121 METROPOLITAN DR. SE DECISION MADE: 10-JUN-11
LIVERPOOL NY 13088 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAX PULSE SYSTEM
MEDICORE CO., LTD. 510(k) NO: K110374(TRADITIONAL)
ATTN: YOO BYUNG-KUK PHONE NO : 822 205 62650
3F, SAMWOO B/D, 339-2, JAMSIL DONGSE DECISION MADE: 13-JUN-11
SEOUL KS 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11
ETHICON ENDO-SUGERY, LLC 510(k) NO: K101990(TRADITIONAL)
ATTN: DONOVAN MAY PHONE NO : 513 337 7981
4545 CREEK RD. SE DECISION MADE: 13-JUN-11
CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MECTALIF
MEDACTA INTERNATIONAL 510(k) NO: K110927(TRADITIONAL)
ATTN: ADAM GROSS PHONE NO : 805 437 7085
4725 CALLE QUETZAL, UNIT B SE DECISION MADE: 13-JUN-11
CAMARILLO CA 93012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
SPINEOLOGY, INC. 510(k) NO: K110933(TRADITIONAL)
ATTN: BRYAN BECKER PHONE NO : 651 256 8534
7800 3RD ST N., SUITE 600 SE DECISION MADE: 13-JUN-11
ST. PAUL MN 55128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
SOLCO BIOMEDICAL CO., LTD. 510(k) NO: K102458(SPECIAL)
ATTN: SAEYOUNG AHN PHONE NO : 301 602 4014
9700 GREAT SENECA HWY SUITE 302 SE DECISION MADE: 13-JUN-11
ROCKVILLE MD 20850 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
TZ MEDICAL, INC. 510(k) NO: K102507(ABBREVIATED)
ATTN: JOHN LUBISICH PHONE NO : 503 639 0282
7272 SW DURHAM RD., #800 SE DECISION MADE: 13-JUN-11
PORTLAND OR 97224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPACELABS PATHFINDER SL HOLTER ANALYZER
SPACELABS HEALTHCARE LTD. 510(k) NO: K110001(TRADITIONAL)
ATTN: THOMAS KROENKE PHONE NO : 303 956 4232
PO BOX 3018 SE DECISION MADE: 14-JUN-11
NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDROFIX SURGICAL SHEET
MIMEDX GROUP, INC 510(k) NO: K100313(TRADITIONAL)
ATTN: SALLY THORSEN PHONE NO : 678 384 6720
811 LIVINGSTON COURT SE SUITE B SE DECISION MADE: 14-JUN-11
MARIETTA GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPFLEX
KERR CORPORATION 510(k) NO: K110747(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714 516 7602
1717 WEST COLLINS AVENUE SE DECISION MADE: 14-JUN-11
ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
TORNIER, INC. 510(k) NO: K110599(TRADITIONAL)
ATTN: BRAHIM HADRI PHONE NO : 978 232 9997
7701 FRANCE AVE SOUTH SUITE 600 SE DECISION MADE: 14-JUN-11
EDINA MN 55435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADDITIVE CAP
BAXTER HEALTHCARE CORP. 510(k) NO: K111217(TRADITIONAL)
ATTN: NANETTE HEDDEN PHONE NO : 847 270 4871
1620 WAULKEGAN RD. SE DECISION MADE: 14-JUN-11
MCGAW PARK IL 60085 6730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
COOK, INC. 510(k) NO: K111244(SPECIAL)
ATTN: MIRONDA CARPENTER PHONE NO : 812 339 2235
750 DANIELS WAY P.O. BOX 489 SE DECISION MADE: 14-JUN-11
BLOOMINGTON IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENTELLUS MEDICAL SINUS GUIDEWIRE
ENTELLUS MEDICAL, INC. 510(k) NO: K110739(TRADITIONAL)
ATTN: KAREN E PETERSON PHONE NO : 763 463 7056
6705 WEDGWOOD COURT NORTH SE DECISION MADE: 14-JUN-11
MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EV1000 CLINICAL PLATFORM
EDWARDS LIFESCIENCES 510(k) NO: K110597(TRADITIONAL)
ATTN: MARGUERITE THOMLINSON PHONE NO : 949 756 4386
ONE EDWARDS WAY SE DECISION MADE: 14-JUN-11
IRVINE CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEU-26L ELCTRONIC ENDODONTIC SYSTEM
ASEPTICO, INC. 510(k) NO: K111078(ABBREVIATED)
ATTN: GRANT RAMALEY PHONE NO : 425 487 3157
8333 216TH ST., S.E. SE DECISION MADE: 14-JUN-11
WOODINVILLE WA 98072 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES
COMFORT RUBBER GLOVES INDUSTRIES S510(k) NO: K110297(TRADITIONAL)
ATTN: TAN KENG BENG PHONE NO : 605 847 2777
LOT 821, JALAN MATANG SE DECISION MADE: 15-JUN-11
TAIPING, PERAK MY 34750 510(k) STATEMENT
DEVICE: PONTO PRO POWER
OTICON MEDICAL AB 510(k) NO: K103594(TRADITIONAL)
ATTN: ULRIKA NIELSEN PHONE NO : 463 174 86100
EKONOMIV 2 SE DECISION MADE: 15-JUN-11
GOTHENBURG, ASKIM SW SE-436 33 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSPINE VBR SYSTEM
AESCULAP IMPLANT SYSTEMS, LLC 510(k) NO: K110864(TRADITIONAL)
ATTN: LISA BOYLE PHONE NO : 610 984 9274
3773 CORPORATE PARKWAY SE DECISION MADE: 15-JUN-11
CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISENSIA, VISENSIA WITH ALERT
OBS MEDICAL 510(k) NO: K110953(SPECIAL)
ATTN: CHRIS WEATHERALL PHONE NO : 013 677 10208
ROSEMARY HOUSE 31 CHURCH GREEN STASE DECISION MADE: 15-JUN-11
IN THE VALE OXFORD UK SN7 8HU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MD301C4 29.8" DIAGNOSTIC IMAGING LCD MONITOR, L309TY
NEC DISPLAY SOLUTIONS, LTD. 510(k) NO: K111237(TRADITIONAL)
ATTN: ANGUS HSU PHONE NO : 886 226 037288
1F, NO. 181, SEC. 2 WUNHUA 1ST ROASE DECISION MADE: 15-JUN-11
NEW TAIPEI CITY TW 2447 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS
NOBEL BIOCARE USA LLC 510(k) NO: K110171(SPECIAL)
ATTN: HERBERT CRANE PHONE NO : 714 282 4800
22715 SAVI RANCH PARKWAY SE DECISION MADE: 15-JUN-11
YORBA LINDA CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AZUR DETACHABLE 35 PLATINUM COIL SYSTEM
MICROVENTION, INC. 510(k) NO: K111307(TRADITIONAL)
ATTN: LARAINE PANGELINA PHONE NO : 714 247 8150
1311 VALENCIA AVE SE DECISION MADE: 15-JUN-11
TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLONOSCOPY ASSISTANT
STI MEDICAL SYSTEMS, LLC 510(k) NO: K102949(TRADITIONAL)
ATTN: ROLF WOLTERS PHONE NO : 808 540 4728
99-193 AIEA HEIGHTS DRIVE SE DECISION MADE: 15-JUN-11
AIEA HI 96701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT
ARVIK ENTERPRISES/ MINI LAP TECHNO510(k) NO: K102274(TRADITIONAL)
ATTN: CURTIS RAYMOND PHONE NO : 203 922 0105
80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 15-JUN-11
SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301
AG DIGITAL TECHNOLOGY CORP. 510(k) NO: K101641(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928 863 8140
2904 N. BOLDT DRIVE SE DECISION MADE: 16-JUN-11
FLAGSTAFF AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUARDACARE
HEMCON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K103641(TRADITIONAL)
ATTN: KEVIN HAWKINS PHONE NO : 503 245 0459
10575 SW CASCADE AVENUE SUITE 130 SE DECISION MADE: 16-JUN-11
PORTLAND OR 97223 4363 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENCOR ENSPIRE BREAST BIOPSY SYSTEM
C.R. BARD, INC. 510(k) NO: K111100(SPECIAL)
ATTN: JUSTIN LOVELACE PHONE NO : 480 638 2915
1415 WEST 3RD ST. SE DECISION MADE: 16-JUN-11
TEMPE AZ 85281 1740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TULA IONTOPHORESIS SYSTEM
ACCLARENT, INC. 510(k) NO: K110636(TRADITIONAL)
ATTN: GURVINDER SINGH NANDA PHONE NO : 650 687 5414
1525-B O'BRIEN DR. SE DECISION MADE: 16-JUN-11
MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELTA WOUND CLEANSER
SWISS AMERICAN PRODUCTS, INC. 510(k) NO: K103713(TRADITIONAL)
ATTN: ERIC LUO PHONE NO : 972 385 2900
2055 LUNA RD., STE. 126 SE DECISION MADE: 16-JUN-11
CARROLLTON TX 75006 510(k) STATEMENT
DEVICE: APEX K1 HIP STEM
OMNILIFE SCIENCE INC. 510(k) NO: K110947(SPECIAL)
ATTN: RADHIKA PONDICHERRY PHONE NO : 774 226 1852
50 O'CONNELL WAY SE DECISION MADE: 16-JUN-11
EAST TAUNTON MA 02718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC
FIAB S.P.A. 510(k) NO: K103783(TRADITIONAL)
ATTN: ALBERTO CALABRO PHONE NO : 39 055 8497943
VIA COSTOLI, 4 SE DECISION MADE: 16-JUN-11
VICCHIO FLORENCE IT 50039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
PREMIER MEDICAL GLOVES FACTORY 510(k) NO: K111297(TRADITIONAL)
ATTN: LIANG ZHAO PHONE NO : 865 362 197069
NO. 8-2, XING'AN RD., DONGCHENG, LSE DECISION MADE: 16-JUN-11
WEIFANG, SHANDONG CH 262600 510(k) STATEMENT
DEVICE: BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX
GE MEDICAL SYSTEMS, LLC 510(k) NO: K103476(TRADITIONAL)
ATTN: NIDHI CHAUDHARY PHONE NO : 414 721 2899
3000 N GRANDVIEW BLVD. SE DECISION MADE: 16-JUN-11
WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXFIRE MARXMEN MENISCAL REPAIR DEVICE
BIOMET SPORTS MEDICINE 510(k) NO: K111564(SPECIAL)
ATTN: ELIZABETH WRAY PHONE NO : 574 371 1176
56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 16-JUN-11
WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
JIANGSU ALFA GLOVE CO., LTD 510(k) NO: K111459(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 108 2387441
RM.1606, BLDG.1 JIANXIANG YUAN NO.SE DECISION MADE: 16-JUN-11
HAI DIAN DISTRICT, BEIJING CH 1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLINE EPIDURAL AND SPINAL NEEDLES
MEDLINE, INDUSTRIES, INC. 510(k) NO: K110194(TRADITIONAL)
ATTN: MATT CLAUSEN PHONE NO : 847 643 4785
ONE MEDLINE PLACE SE DECISION MADE: 17-JUN-11
MUNDELEIN IL 60060 510(k) STATEMENT
DEVICE: TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES
CAREFUSION 209, INC. 510(k) NO: K111131(SPECIAL)
ATTN: GLEN HERMANSON PHONE NO : 608 829 8606
1850 Deming Way SE DECISION MADE: 17-JUN-11
Middleton WI 53562 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIT CHECKER ADVANCED
GC AMERICA, INC. 510(k) NO: K110871(TRADITIONAL)
ATTN: MARK HEISS PHONE NO : 708 897 4042
3737 WEST 127TH ST. SE DECISION MADE: 17-JUN-11
ALSIP IL 60803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE
SMART MEDICAL SYSTEMS, LTD. 510(k) NO: K110291(SPECIAL)
ATTN: ADVA YOSELZON PHONE NO : 972 974 44478
10 HAYETSIRA STREET SE DECISION MADE: 17-JUN-11
RAANANA IS 43663 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRISMAFLEX
GAMBRO RENAL PRODUCTS, INC. 510(k) NO: K110823(TRADITIONAL)
ATTN: KAE MILLER PHONE NO : 303 222 6724
14143 DENVER WEST PARKWAY SUITE 40SE DECISION MADE: 17-JUN-11
LAKEWOOD CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIXTEMP C&B
EXACTA DENTAL DIRECT, INC 510(k) NO: K102917(TRADITIONAL)
ATTN: RICHARD KEEN PHONE NO : 203 329 2700
1151 HOPE STREET SE DECISION MADE: 17-JUN-11
STAMFORD CT 06907 1659 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM
ORTHOPEDIATRICS, CORP 510(k) NO: K111086(TRADITIONAL)
ATTN: MARK FOX PHONE NO : 574 268 6379
2850 FRONTIER DRIVE SE DECISION MADE: 17-JUN-11
WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFETYMATE TALKING FIRST AID
SAFETYMATE, INC. 510(k) NO: K110625(TRADITIONAL)
ATTN: SHARON COHEN, PH.D PHONE NO : 949 722 1121
1633 MONROVIA AVE SE DECISION MADE: 17-JUN-11
COSTA MCSA CA 92627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CENTRIMAG RETURN CANNULA KIT
LEVITRONIX LLC. 510(k) NO: K110980(TRADITIONAL)
ATTN: LYDIA SAKAKEENY PHONE NO : 781 466 6553
45 FIRST AVE. SE DECISION MADE: 20-JUN-11
WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908
EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K110509(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 678 908 8180
845 ARONSON LAKE COURT SE DECISION MADE: 20-JUN-11
ROSWELL GA 30075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMATE STERILE ACUPUNCTURE NEEDLE
BIOMATE MEDICAL DEVICES TECHNOLOGY510(k) NO: K103061(TRADITIONAL)
ATTN: MICHAEL LEE PHONE NO : 886 228 096995
NO.45, MINSHENG RD. DANSHUI TOWN SE DECISION MADE: 20-JUN-11
TAIPEI COUNTY TW 251 510(k) STATEMENT
DEVICE: BIODESIGN NIPPLE RECONSTRUCTION CYLINDER
COOK BIOTECH, INC. 510(k) NO: K110402(TRADITIONAL)
ATTN: PERRY W GUINN PHONE NO : 765 497 3355
1425 INNOVATION PLACE SE DECISION MADE: 20-JUN-11
WEST LAFAYETTE IN 47906 1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
IND DIAGNOSTICS INC. 510(k) NO: K110889(TRADITIONAL)
ATTN: KAI LOU PHONE NO : 604 522 1619
1629 FOSTERS WAY SE DECISION MADE: 20-JUN-11
DELTA, BRITISH COLUMBIA CA V3M 510(k) STATEMENT
DEVICE: CENTRIMAG DRAINAGE CANNULA KIT
LEVITRONIX LLC 510(k) NO: K110983(TRADITIONAL)
ATTN: LYDIA SAKAKEENY PHONE NO : 781 466 6553
45 FIRST AVE. SE DECISION MADE: 20-JUN-11
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE LONG LATERAL SPINAL SYSTEM
NUVASIVE, INC. 510(k) NO: K111410(SPECIAL)
ATTN: ELIAS KETCHUM PHONE NO : 858 320 4588
7475 LUSK BLVD SE DECISION MADE: 20-JUN-11
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT
ASTRA TECH AB 510(k) NO: K101005(SPECIAL)
ATTN: LINDA SCHULZ PHONE NO : 858 792 1235
11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 21-JUN-11
SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENSCARE ITOUCH SURE MODEL ITS
TENSCARE LTD. 510(k) NO: K103698(TRADITIONAL)
ATTN: ANDREW BROWN PHONE NO : 441 367 723434
9 BLENHEIM ROAD SE DECISION MADE: 21-JUN-11
EPSOM, SURREY UK KT19 9BE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH
ELITECHGROUP 510(k) NO: K110830(TRADITIONAL)
ATTN: DEBRA K HUTSON PHONE NO : 425 482 5174
21720 23RD DR SE SUITE 150 SE DECISION MADE: 21-JUN-11
BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL
SONITUS MEDICAL INC 510(k) NO: K110831(TRADITIONAL)
ATTN: ROBERT J CHIN, PH.D. PHONE NO : 650 593 5225
25 HARTFORD AVENUE SE DECISION MADE: 21-JUN-11
SAN CARLOS CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
ORTHOFIX INC. 510(k) NO: K110805(SPECIAL)
ATTN: MARY BIGGERS PHONE NO : 972 824 4624
3451 PLANO PARKWAY SE DECISION MADE: 21-JUN-11
LEWISVILLE TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE
GALIL MEDICAL LTD. 510(k) NO: K110946(SPECIAL)
ATTN: LYNNE DAVIES PHONE NO : 651 287 5098
YOKNEAM GATE, 1 TAVOR BLDG. SE DECISION MADE: 21-JUN-11
YOKNEAM IS 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CT-GUIDE NEEDLE GUIDANCE SYSTEM
ACTIVIEWS LTD 510(k) NO: K110812(TRADITIONAL)
ATTN: JOHN J SMITH PHONE NO : 202 637 3638
555 THIRTEENTH STREET, NW SE DECISION MADE: 21-JUN-11
WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANASCIENT BREATH MONITOR
INVOY TECHNOLOGIES, LLC 510(k) NO: K110810(TRADITIONAL)
ATTN: LUBNA M AHMAD PHONE NO : 602 721 0377
1820 E.RAY ROAD SE DECISION MADE: 21-JUN-11
CHANDLER AZ 85225 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: QLAB 8.1 QUANTIFICATION SOFTWARE
PHILIPS ULTRASOUND, INC. 510(k) NO: K110414(TRADITIONAL)
ATTN: NANCY BURKE PHONE NO : 425 487 7371
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 21-JUN-11
BOTHELL WA 98041 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042
EPS BIO TECHNOLOGY CORP. 510(k) NO: K102345(SPECIAL)
ATTN: Y.C. LEI PHONE NO : 886 3 6686868
NO.8 R&D RD III HSINCHU SCIENCE PASE DECISION MADE: 21-JUN-11
HSINCHU CITY TW 30077 510(k) STATEMENT
DEVICE: UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K111444(SPECIAL)
ATTN: SUZANA OTANO PHONE NO : 305 269 6386
700 ORTHOPAEDIC DRIVE SE DECISION MADE: 22-JUN-11
WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTEP
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K111394(TRADITIONAL)
ATTN: SHANNON POPSON PHONE NO : 916 374 3330
1584 ENTERPRISE BLVD SE DECISION MADE: 22-JUN-11
WEST SACRAMENTO CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX PS KNEE SYSTEM - PS-C INSERT
OMNILIFE SCIENCE INC. 510(k) NO: K111184(SPECIAL)
ATTN: RADHIKA PONDICHERRY PHONE NO : 774 226 1852
50 O'CONNELL WAY SE DECISION MADE: 22-JUN-11
EAST TAUNTON MA 02718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALEUTIAN SPACER SYSTEM
K2M, INC. 510(k) NO: K110843(SPECIAL)
ATTN: NANCY GIEZEN PHONE NO : 703 777 3155
751 MILLER DR. SE, SUITE F1 SE DECISION MADE: 22-JUN-11
LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE PICC WAND (R) PEELABLE SAFETY INTRODUCER
ACCESS SCIENTIFIC, INC. 510(k) NO: K111138(SPECIAL)
ATTN: ALBERT MISAJON PHONE NO : 858 259 8333
12526 HIGH BLUFF DRIVE SUITE 360 SE DECISION MADE: 22-JUN-11
SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS
SMITH & NEPHEW, INC. 510(k) NO: K110647(TRADITIONAL)
ATTN: LAURA REYNOLDS PHONE NO : 727 329 7702
970 LAKE CARILLON DR. SE DECISION MADE: 22-JUN-11
ST. PETERSBURG FL 33716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALOMAR ICON (TM) AESTHETIC SYSTEM
PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K110907(TRADITIONAL)
ATTN: SHARON TIMBERLAKE PHONE NO : 781 993 2414
15 NETWORK DRIVE SE DECISION MADE: 22-JUN-11
BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORELEADER ALGIPLASTER MODEL AP 050501
CORELEADER BIOTECH CO., LTD. 510(k) NO: K102942(TRADITIONAL)
ATTN: IAN LI PHONE NO : 886 226 968880
19F NO. 100, SEC 1 SINTAI 5TH RD, SE DECISION MADE: 22-JUN-11
TAIPEI, TAIWAN TW 22102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGIVISION INC. CLEARPOINT SYSTEM
SURGI-VISION, INC. 510(k) NO: K111073(TRADITIONAL)
ATTN: EDWARD WADDELL PHONE NO : 949 900 6833
5 MUSICK SE DECISION MADE: 22-JUN-11
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE SENSITITRE AIM
TREK DIAGNOSTIC SYSTEMS 510(k) NO: K103456(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 216 351 8735
982 KEYNOTE CIRCLE SE DECISION MADE: 22-JUN-11
CLEVELAND OH 44131 510(k) STATEMENT
DEVICE: CUTERA QSWITCH LASER SYSTEM
CUTERA, INC. 510(k) NO: K102954(TRADITIONAL)
ATTN: CONNIE HOY PHONE NO : 415 657 5592
3240 BAYSHORE BLVD SE DECISION MADE: 22-JUN-11
BRISBANE CA 94005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
AALTO SCIENTIFIC LTD. 510(k) NO: K100716(TRADITIONAL)
ATTN: DESSI LYAKOV PHONE NO : 760 431 7922
1959 KELLOGG AVE. SE DECISION MADE: 23-JUN-11
CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WART FREEZE
KONINKLIJKE UTERMOHLEN NV 510(k) NO: K101049(TRADITIONAL)
ATTN: SHIRLEY FURESZ PHONE NO : 905 689 3980
4 INNOVATION DRIVE SE DECISION MADE: 23-JUN-11
DUNDAS, ONTARIO CA L9H 7P3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIVE WASTE GAS SCAVENGER
G. DUNDAS CO.,INC. 510(k) NO: K110930(SPECIAL)
ATTN: MICHELLE NORRIE PHONE NO : 253 631 8008
24301 ROBERTS DR. SE DECISION MADE: 23-JUN-11
BLACK DIAMOND WA 98010 510(k) STATEMENT
DEVICE: SURGICAL PROCEDURE PACKS
OMNIA SPA 510(k) NO: K110724(TRADITIONAL)
ATTN: JAMIE AUSTIN PHONE NO : 317 569 9500
11460 N MERIDIAN STREET SUITE 150 SE DECISION MADE: 23-JUN-11
CARMEL IN 46032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INOMAX DS(IR) (DELIVERY SYSTEM)
INO THERAPEUTICS LLC/DBA IKARIA 510(k) NO: K110635(SPECIAL)
ATTN: LARRY LEPLEY PHONE NO : 608 226 3415
2902 Dairy Dr SE DECISION MADE: 23-JUN-11
MADISON WI 53718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISTA DIGITAL OPTHALMOSCOPE
EYEQUICK.LLC 510(k) NO: K102412(TRADITIONAL)
ATTN: MARC ELLMAN MD PHONE NO : 915 490 1766
1400 COMMON DRIVE SE DECISION MADE: 23-JUN-11
EL PASO,TX TX 79936 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAT-MAT MINOR
MACPHERSON MEDICAL, INC. 510(k) NO: K110500(TRADITIONAL)
ATTN: HOWARD HOLSTEIN PHONE NO : 202 637 5813
555 13TH STREET, NW COLUMBIA SQUARSE DECISION MADE: 23-JUN-11
WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUROS PORT PROTECTOR
IVERA MEDICAL 510(k) NO: K110826(ABBREVIATED)
ATTN: DON CANAL PHONE NO : 888 861 8228
2731 Loker Avenue West SE DECISION MADE: 23-JUN-11
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K110239(TRADITIONAL)
ATTN: BERNICE LIN PHONE NO : 408 732 3856
670 ALMANOR AVENUE SE DECISION MADE: 23-JUN-11
SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOUND SURGICAL VASER 2.1 LIPO SYSTEM
SOUND SURGICAL TECHNOLOGIES LLC. 510(k) NO: K110306(TRADITIONAL)
ATTN: STEPHEN C SMITH PHONE NO : 720 240 2970
357 S. MCCASLIN BLVD. #100 SE DECISION MADE: 23-JUN-11
LOUISVILLE CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CENTURION PRESSURE INJECTABLE EXTENSION SET
CENTURION MEDICAL PRODUCTS CORPORA510(k) NO: K103562(ABBREVIATED)
ATTN: MATTHEW K PRICE PHONE NO : 517 546 5400
100 CENTURION WAY SE DECISION MADE: 23-JUN-11
WILLIAMSTON MI 48895 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE
NOBEL BIOCARE AB 510(k) NO: K111581(SPECIAL)
ATTN: HERBERT CRANE PHONE NO : 714 282 4800
22715 SAVI RANCH PARKWAY SE DECISION MADE: 23-JUN-11
YORBA LINDA CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METAL OPAQUER
APEX DENTAL MATERIALS, INC. 510(k) NO: K110859(TRADITIONAL)
ATTN: CHRIS KULTON PHONE NO : 847 719 1133
330 TELSER ROAD SE DECISION MADE: 23-JUN-11
LAKE ZURICH IL 60047 510(k) STATEMENT
DEVICE: AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE
MEDTRONIC, INC. 510(k) NO: K111657(SPECIAL)
ATTN: LISA STONE PHONE NO : 763 514 9866
8200 CORAL SEA STREET NE SE DECISION MADE: 23-JUN-11
MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE THYROID COLLAR
BLOXR CORPORATION 510(k) NO: K110900(TRADITIONAL)
ATTN: RAI CHOWDHARY PHONE NO : 385 646 7425
2116 LAKE CITY SE DECISION MADE: 24-JUN-11
SALT LAKE CITY UT 84109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIBERECT PENILE VIBRATORY STIMULATION DEVICE
REFLEXONIC, LLC 510(k) NO: K110566(TRADITIONAL)
ATTN: CAROLINE TONTINI PHONE NO : 512 327 9997
611 WEST 5TH STREET THIRD FLOOR SE DECISION MADE: 24-JUN-11
AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS)
SSC SURAT THANI 510(k) NO: K111133(ABBREVIATED)
ATTN: WILLIAM E HARRIS , III PHONE NO : 727 787 7250
13900 49TH STREET NORTH SE DECISION MADE: 24-JUN-11
CLEARWATER FL 33762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IBAG
FUTURE PATH MEDICAL, LLC 510(k) NO: K110518(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 239 234 1735
8870 RAVELLO CT SE DECISION MADE: 24-JUN-11
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPSY HANDY, MRI BIOPSY HANDY
SOMATEX MEDICAL TECHNOLOGIES GMBH 510(k) NO: K102771(TRADITIONAL)
ATTN: SUSANNE RAAB PHONE NO : 617 547 0628
1480 CAMBRIDGE STREET SE DECISION MADE: 24-JUN-11
CAMBRIDGE MA 02139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F10
MEDIANA CO., LTD. 510(k) NO: K110630(TRADITIONAL)
ATTN: AMY M.H. KIM PHONE NO : 823 374 25400
1650-1 DONGHWA-RI MUNMAK-CUP SE DECISION MADE: 24-JUN-11
WONJU-CITY, GANGWON-DO KS 220-8510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EPIDUCER LEAD DELIVERY SYSTEM
ST. JUDE MEDICAL 510(k) NO: K110609(TRADITIONAL)
ATTN: RASHMI MOZA PHONE NO : 972 309 8055
6901 PRESTON ROAD SE DECISION MADE: 24-JUN-11
PLANO TX 75024 510(k) STATEMENT
DEVICE: MONACO RTP SYSTEM
COMPUTERIZED MEDICAL SYSTEMS, INC.510(k) NO: K110730(TRADITIONAL)
ATTN: KATHRYN STINSON PHONE NO : 314 933 0003
13723 RIVERPORT DR SUITE 100 SE DECISION MADE: 24-JUN-11
MARYLAND HEIGHTS MO 63043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT
VANDUZEN DBA MEDCAD 510(k) NO: K110684(TRADITIONAL)
ATTN: DIANE RUTHERFORD PHONE NO : 972 480 9554
1201 RICHARDSON SUITE 280 SE DECISION MADE: 24-JUN-11
RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERIT MEDICAL 20 ML SYRINGE
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K111091(SPECIAL)
ATTN: MICHAELA RIVKOWICH PHONE NO : 801 208 4196
1600 WEST MERIT PKWY. SE DECISION MADE: 24-JUN-11
SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSI
DIACOUSTIC MEDICAL DEVICES (PTY) L510(k) NO: K110704(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 888 729 9674
1468 HARWELL AVENUE SE DECISION MADE: 24-JUN-11
CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)
SMITH & NEPHEW, INC. 510(k) NO: K110545(TRADITIONAL)
ATTN: ELIZABETH LAVELLE PHONE NO : 508 261 3607
150 MINUTEMAN RD. SE DECISION MADE: 24-JUN-11
ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY
VASOMEDICAL, INC. 510(k) NO: K111096(SPECIAL)
ATTN: RICHARD E GORDON PHONE NO : 516 508 5821
180 LINDEN AVE. SE DECISION MADE: 24-JUN-11
WESTBURY NY 11590 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INOMAX DSIR (DELIVERY SYSTEM)
INO THERAPEUTICS 510(k) NO: K110344(SPECIAL)
ATTN: LARRY LEPLEY PHONE NO : 608 226 3415
2902 DAIRY DRIVE SE DECISION MADE: 24-JUN-11
MADISON WI 53718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CX50 DIAGNOSTIC ULTRASOUND SYSTEM
PHILIPS ULTRASOUND, INC. 510(k) NO: K111513(TRADITIONAL)
ATTN: PENNY GRECO PHONE NO : 978 659 4615
3000 MINUTEMAN ROAD SE DECISION MADE: 24-JUN-11
ANDOVER MA 01810 6302 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SUREFIRE INFUSION CATHETER SYSTEM
SUREFIRE MEDICAL, INC 510(k) NO: K110459(TRADITIONAL)
ATTN: CHERYL HASTINGS PHONE NO : 303 883 5554
8601 TURNPIKE DR SUITE 206 SE DECISION MADE: 24-JUN-11
WESTMINISTER CO 80031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPRIS RETROPUBIC SLING SYSTEM
COLOPLAST A/S 510(k) NO: K111233(SPECIAL)
ATTN: TIM CRABTREE PHONE NO : 612 302 4922
1601 WEST RIVER ROAD N SE DECISION MADE: 24-JUN-11
MINNEAPOLIS MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPAX VOLUME VIEWING
AGFA HEALTHCARE N.V. 510(k) NO: K111638(TRADITIONAL)
ATTN: KOEN COBBAERT PHONE NO : 323 444 7539
SEPTESTRAAT 27 SE DECISION MADE: 24-JUN-11
MORTSEL BE B 2640 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K103520(TRADITIONAL)
ATTN: DARYL RICHARDSON PHONE NO : 949 250 5036
ONE EDWARDS WAY SE DECISION MADE: 24-JUN-11
IRVINE CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K101509(TRADITIONAL)
ATTN: TELING HSU PHONE NO : 886 266 258188
3F,5F, NO.127 WUGONG 2ND RD, WUGU SE DECISION MADE: 27-JUN-11
TAIPEI COUNTY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSENSUS KNEE SYSTEM
CONSENSUS ORTHOPEDICS, INC. 510(k) NO: K110950(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 916 355 7156
1115 WINDFIELD WAY, SUITE 100 SE DECISION MADE: 27-JUN-11
EL DORADO HILLS CA 95762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFLU+ ASSAY
GEN-PROBE PRODESSE, INC 510(k) NO: K110968(TRADITIONAL)
ATTN: KAREN HARRINGTON PHONE NO : 262 953 8415
W229 N1870 WESTWOOD DR SE DECISION MADE: 27-JUN-11
WAUKESHA WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX ARC HIP STEM
OMNILIFE SCIENCE INC. 510(k) NO: K111193(SPECIAL)
ATTN: RADHIKA PONDICHERRY PHONE NO : 774 226 1852
50 O'CONNELL WAY SE DECISION MADE: 27-JUN-11
EAST TAUNTON MA 02718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATIENT MONITOR
CONTEC MEDICAL SYSTEM CO., LTD. 510(k) NO: K101692(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467
SUITE 8D , ZHONGXIN ZHONGSHAN MANSSE DECISION MADE: 28-JUN-11
ZHONG SHAN, SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRYTOUCH SUCTION STIMULATOR PROBE
NEUROVISION MEDICAL PRODUCTS, INC.510(k) NO: K110712(TRADITIONAL)
ATTN: CHRISTINE VERGELY PHONE NO : 805 866 6999
2225 SPERRY AVE, SUITE 1000 SE DECISION MADE: 28-JUN-11
VENTURA CA 93003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IVAS 2-10MM (10 GUAGE) BALLON CATHETER
STRYKER CORPORATION 510(k) NO: K103807(TRADITIONAL)
ATTN: MELISSA KANN PHONE NO : 269 324 7700
4100 E. MILHAM AVE SE DECISION MADE: 28-JUN-11
KALAMAZOO MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITAL SERUM CONTROLS
VITAL DIAGNOSTICS (MANUFACTURING) 510(k) NO: K111063(TRADITIONAL)
ATTN: MELITA LAMBIRIS PHONE NO : 613 879 36300
189-190 BROWNS ROAD SE DECISION MADE: 28-JUN-11
NOBLE PARK VICTORIA AU 3174 510(k) STATEMENT
DEVICE: APTUS FOOT 3.5 SYSTEM
MEDARTIS AG 510(k) NO: K110908(TRADITIONAL)
ATTN: KEVIN A THOMAS PHONE NO : 858 792 1235
11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 28-JUN-11
SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER
HIGHLAND INSTRUMENTS 510(k) NO: K110752(TRADITIONAL)
ATTN: LEO BASTA PHONE NO : 617 834 9866
755 WESTMINSTER STREET UNIT 120 SE DECISION MADE: 28-JUN-11
PROVIDENCE RI 02903 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIPOLAR HF DEVICE
AESCULAP, INC. 510(k) NO: K110695(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610 984 9274
3773 CORPORATE PARKWAY SE DECISION MADE: 28-JUN-11
CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HALIFAX BIOMEDICAL TANATLUM BEAD SET
HALIFAX BIOMEDICAL, INC. 510(k) NO: K103417(SPECIAL)
ATTN: ROBERT A POGGIE, PHD PHONE NO : 973 738 6097
3 ELIZABETH PLACE SE DECISION MADE: 28-JUN-11
LAKE HOPATCONG NJ 07849 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INDIKO
THERMO FISHER SCIENTIFIC OY 510(k) NO: K110035(TRADITIONAL)
ATTN: PAIVI SORMUNEN PHONE NO : 358 932 910762
RATASTIE 2 SE DECISION MADE: 28-JUN-11
VANTAA FI 01620 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDART DIODE LASER SYSTEM & ACCESSORIES
MEDART A/S 510(k) NO: K110243(TRADITIONAL)
ATTN: JOANNE DAVIES PHONE NO : 441 792 798768
CLOS LLYN CWM SE DECISION MADE: 28-JUN-11
SWANSEA, WALES UK SA6 8QY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY
VASOMEDICAL, INC. 510(k) NO: K111180(SPECIAL)
ATTN: RICHARD E GORDON PHONE NO : 516 508 5821
180 LINDEN AVE. SE DECISION MADE: 28-JUN-11
WESTBURY NY 11590 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
MEDTRONIC INC. 510(k) NO: K111658(SPECIAL)
ATTN: LISA STONE PHONE NO : 763 514 9866
8200 CORAL SEA ST NE SE DECISION MADE: 28-JUN-11
MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM
MEDTEC, INC. 510(k) NO: K111340(TRADITIONAL)
ATTN: JENNY JONES PHONE NO : 712 737 8688
1401 8TH STREET SE SE DECISION MADE: 28-JUN-11
ORANGE CITY IA 51041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASICO SOFTIP INJECTOR SYSTEM
ASICO LLC 510(k) NO: K103495(TRADITIONAL)
ATTN: RAVI NALLAKRISHNAN PHONE NO : 630 986 8032
26 PLAZA DR. SE DECISION MADE: 29-JUN-11
WESTMONT IL 60559 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
MICROGENICS CORP. 510(k) NO: K110616(TRADITIONAL)
ATTN: LISA CHARTER PHONE NO : 510 979 5142
46360 FREMONT BLVD SE DECISION MADE: 29-JUN-11
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT
COOPERVISION, INC. 510(k) NO: K110099(TRADITIONAL)
ATTN: SARAH HARRINGTON PHONE NO : 925 621 2458
6150 STONERIDGE MALL ROAD SUITE 37SE DECISION MADE: 29-JUN-11
PLEASANTON CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORIN MINIHIP FEMORAL STEM
CORIN USA 510(k) NO: K111046(SPECIAL)
ATTN: LUCINDA GERBER PHONE NO : 813 977 4469
10500 UNIVERSITY CENTER DRIVE SUITSE DECISION MADE: 29-JUN-11
TAMPA FL 33612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAVEGUARD (TM) EEG CAP
EEMAGINE MEDICAL IMAGING SOLUTIONS510(k) NO: K110223(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 239 234 1735
8870 RAVELLO CT SE DECISION MADE: 29-JUN-11
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAX ORIENT SUCTION DEVICE FOR ELECTROCAUTERIZER
PACIFIC HOSPITAL SUPPLY CO., LTD 510(k) NO: K111672(TRADITIONAL)
ATTN: IRENE LIN PHONE NO : 886 228 955050
4F, NO. 160, DAYE RD, BEITOU DIST.SE DECISION MADE: 29-JUN-11
TAIPEI TW 112 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OCTANE-C INTERBODY FUSION DEVICE SYSTEM
EXACTECH, INC. 510(k) NO: K103655(TRADITIONAL)
ATTN: PATRICK HUGHES PHONE NO : 352 377 1140
2320 N.W. 66TH CT. SE DECISION MADE: 30-JUN-11
GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZONO 3000
LIFE-TECH, INC. 510(k) NO: K102813(TRADITIONAL)
ATTN: SKIP RIMER PHONE NO : 281 491 6600
13235 NORTH PROMENADE BLVD. SE DECISION MADE: 30-JUN-11
STAFFORD TX 77477 510(k) STATEMENT
DEVICE: SCANORA 3D
SOREDEX PALODEX GROUP OY 510(k) NO: K110839(TRADITIONAL)
ATTN: MATTI TULIKOURA PHONE NO : 358 400 609507
NAHKELANTIE 160 SE DECISION MADE: 30-JUN-11
TUUSULA FI FIN-04300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE
MEDLINE INDUSTRIES, INC. 510(k) NO: K102177(ABBREVIATED)
ATTN: MATT CLAUSEN PHONE NO : 847 643 4785
ONE MEDLINE PLACE SE DECISION MADE: 30-JUN-11
MUNDELEIN IL 60060 510(k) STATEMENT
DEVICE: SPIKETRAX SYSTEM
NEURALYNX INC 510(k) NO: K110967(TRADITIONAL)
ATTN: MIKE JOHNSON PHONE NO : 406 585 4542
105 COMMERCIAL DRIVE SE DECISION MADE: 30-JUN-11
BOZEMAN MT 59715 2217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROVU (TM) DENTAL X-RAY SYSTEM
ADVANCED IMAGE SCIENCE, INC. 510(k) NO: K102573(TRADITIONAL)
ATTN: PAUL ROCKWELL PHONE NO : 408 879 2619
1999 SOUTH BASOM AVENUE, SUITE 700SE DECISION MADE: 30-JUN-11
CAMPBELL CA 95008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S8 ASPEN WITH H4I PLUS
RESMED CORP. 510(k) NO: K111148(SPECIAL)
ATTN: DAVID D'CRUZ PHONE NO : 858 836 5984
9001 SPECTRUM CENTER BOULEVARD SE DECISION MADE: 30-JUN-11
KEARNY MESA CA 92123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC...
TELEFLEX MEDICAL, INC. 510(k) NO: K111117(SPECIAL)
ATTN: SUZANNE SCHORLE PHONE NO : 610 378 0131
2400 BERNVILLE ROAD SE DECISION MADE: 30-JUN-11
READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GMD UNIVERSAL URINARY INCONTINENCE SLING
GENERIC MEDICAL DEVICE, INC. 510(k) NO: K111219(TRADITIONAL)
ATTN: JEFF MORGAN PHONE NO : 253 208 3430
PO BOX 818 SE DECISION MADE: 30-JUN-11
OCEAN SHORES WA 98569 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE
NORITAKE CO., INC. 510(k) NO: K111107(TRADITIONAL)
ATTN: IVAN WASSERMAN PHONE NO : 202 585 6529
700 12 STREET, N.W., SUITE 1100 SE DECISION MADE: 30-JUN-11
WASHINGTON DC 20005 510(k) STATEMENT
DEVICE: CLIO/CLIOSOFT
SOTA PRECISION OPTICS, INC. 510(k) NO: K110886(TRADITIONAL)
ATTN: BRIAN KIM PHONE NO : 714 532 6100
1073 NORTH BATAVIA ST. SUITE B SE DECISION MADE: 30-JUN-11
ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIROCCO THERMAL REGULATING SYSTEM
GALMAZ BIOTECH S.L. 510(k) NO: K102856(TRADITIONAL)
ATTN: CHRIS ZANDER PHONE NO : 651 315 8304
1064 LABARGE SE DECISION MADE: 30-JUN-11
HUDSON WI 54016 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ZYSTON ARC INTERBODY SPACER
BIOMET SPINE (AKA EBI, LLC) 510(k) NO: K110650(TRADITIONAL)
ATTN: MARGARET F CROWE PHONE NO : 973 299 9300
100 INTERPACE PARKWAY SE DECISION MADE: 30-JUN-11
PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K111485(TRADITIONAL)
ATTN: ERIC ELLIOTT PHONE NO : 763 494 2671
ONE SCIMED PLACE SE DECISION MADE: 30-JUN-11
MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003
BRIDGEPOINT MEDICAL 510(k) NO: K111488(SPECIAL)
ATTN: JILL MUNSINGER PHONE NO : 763 225 8500
2800 CAMPUS DR STE 50 SE DECISION MADE: 30-JUN-11
PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FATHOM (TM) 14 STEERABLE GUIDEWIRE
BOSTON SCIENTIFIC CORP. 510(k) NO: K111498(TRADITIONAL)
ATTN: ERIC ELLIOTT PHONE NO : 763 494 2671
ONE SCIMED PLACE SE DECISION MADE: 30-JUN-11
MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC AADVA BO AC ABUTMENTS
GC AMERICA, INC. 510(k) NO: K103234(TRADITIONAL)
ATTN: CARL JENKINS PHONE NO : 847 234 7500
10 E. SCRANTON AVENUE SUITE 201 SE DECISION MADE: 30-JUN-11
LAKE BLUFF IL 60044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K111674(TRADITIONAL)
ATTN: SHELLY PEARCE PHONE NO : 650 694 5988
1230 SHOREBIRD WAY SE DECISION MADE: 30-JUN-11
MOUNTAIN VIEW CA 94043 1344 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 240
TOTAL WITH SUMMARIES 221
TOTAL WITH STATEMENTS 19
