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510(k)s Final Decisions Rendered for July 2005 |
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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-JUL-2005 THROUGH 31-JUL-2005
DEVICE: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100
3M COMPANY 510(k) NO: K051790(SPECIAL)
ATTN: GINGER CANTOR PHONE NO : 651-736-2101
3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 25-JUL-05
ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUTURE WASH/YPS
3M ESPE AG DENTAL PRODUCTS 510(k) NO: K051797(SPECIAL)
ATTN: ANDREAS PETERMANN PHONE NO : +49 815 27001395
ESPE PLATZ SE DECISION MADE: 21-JUL-05
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3TP WORKSPACE
3TP LLC 510(k) NO: K050862(TRADITIONAL)
ATTN: MICHAEL KOCHIAN PHONE NO : 914-313-0352
245 MAIN ST., SUITE 620 SE DECISION MADE: 25-JUL-05
WHITE PLAINS, NY 10601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM
ABAXIS, INC. 510(k) NO: K051108(TRADITIONAL)
ATTN: DENNIS M BLEILE PHONE NO : 510-675-6515
3240 WHIPPLE RD. SE DECISION MADE: 08-JUL-05
UNION CITY, CA 94587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELL-DYN SAPPHIRE SYSTEM
ABBOTT LABORATORIES 510(k) NO: K051215(TRADITIONAL)
ATTN: MICHELLE ROEDING PHONE NO : 408-567-3781
5440 PATRICK HENRY DR. SE DECISION MADE: 21-JUL-05
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE
ACE SURGICAL SUPPLY CO., INC. 510(k) NO: K051381(TRADITIONAL)
ATTN: J. EDWARD CARCHIDI PHONE NO : 508-588-3100
1034 PEARL ST. SE DECISION MADE: 15-JUL-05
BROCKTON, MA 02301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUMED RIB CONGRIENT BONE PLATE SYSTEM
ACUMED LLC 510(k) NO: K051410(TRADITIONAL)
ATTN: ED BOEHMER PHONE NO : 503-627-9957
5885 NW CORNELIUS PASS RD. SE DECISION MADE: 21-JUL-05
HILLSBORO, OR 97124-9432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LENS PLUS REWETTING DROPS
ADVANCED MEDICAL OPTICS, INC. 510(k) NO: K042562(ABBREVIATED)
ATTN: PETER XU PHONE NO : 714-247-8592
1700 E. ST. ANDREW PLACE SE DECISION MADE: 29-JUL-05
P.O. BOX 25162 510(k) SUMMARY AVAILABLE FROM FDA
SANTA ANA, CA 92705-4933
DEVICE: OMEGA EXCEL/XP LASER SYSTEM
ADVANCED MEDICAL TECHNOLOGIES, INC510(k) NO: K043353(TRADITIONAL)
ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433
12101 CULLEN BLVD., #A SE DECISION MADE: 01-JUL-05
HOUSTON, TX 77047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S4 SPINAL SYSTEM
AESCULAP, INC. 510(k) NO: K050979(TRADITIONAL)
ATTN: JOYCE KILROY PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 27-JUL-05
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDRALOK SYSTEM
ALTIVA CORP. 510(k) NO: K051216(TRADITIONAL)
ATTN: JOHN KAPITAN PHONE NO : 704-409-1754
9800-I SOUTHERN PINE BLVD. SE DECISION MADE: 19-JUL-05
CHARLOTTE, NC 28273 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
ALVEOLUS, INC. 510(k) NO: K051621(TRADITIONAL)
ATTN: DONALD V CANAL PHONE NO : 704-926-4837
9013 PERIMETER WOODS SUITE A SE DECISION MADE: 11-JUL-05
CHARLOTTE, NC 28216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPID READER
AMERICAN BIO MEDICA CORP. 510(k) NO: K041696(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT ST. SE DECISION MADE: 12-JUL-05
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K051530(SPECIAL)
ATTN: DENISE THOMPSON PHONE NO : 952-930-6489
10700 BREN RD., WEST SE DECISION MADE: 08-JUL-05
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSINO ENDOTRACHEAL TUBE
AMSINO INTERNATIONAL, INC. 510(k) NO: K050785(TRADITIONAL)
ATTN: CHING CHING SEAH PHONE NO : 909-626-5888
855 TOWNE CENTER DRIVE SE DECISION MADE: 15-JUL-05
POMONA, CA 91767 510(k) STATEMENT
DEVICE: ANGIODYNAMICS TUMESCENT INFUSION DEVICE
ANGIODYNAMICS, INC. 510(k) NO: K051142(TRADITIONAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 13-JUL-05
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: INSTANT-X, MODELS 1713 & 128
ANN ARBOR DIGITAL DEVICES 510(k) NO: K042791(TRADITIONAL)
ATTN: WILLIAM J O'NEILL PHONE NO : 734-834-5156
699 SKYNOB COURT SE DECISION MADE: 01-JUL-05
ANN ARBOR, MI 48105 510(k) STATEMENT
DEVICE: NOMAD DENTAL X-RAY SYSTEM
ARIBEX, INC. 510(k) NO: K051795(TRADITIONAL)
ATTN: D.CLARK TURNER PHONE NO : 801-226-5522
754 SOUTH 400 EAST SE DECISION MADE: 14-JUL-05
OREM, UT 84097 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ENDOSSEOUS DENTAL IMPLANT ABUTMENT
ATLANTIS COMPONENTS, INC. 510(k) NO: K051011(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847-560-4406
8944 TAMAROA TERRACE SE DECISION MADE: 12-JUL-05
SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS ABUTMENT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI+ AB
ATLANTIS COMPONENTS, INC. 510(k) NO: K051652(TRADITIONAL)
ATTN: BETSY BROWN PHONE NO : 847-560-4406
8944 TAMAROA TERRACE SE DECISION MADE: 22-JUL-05
SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIOM EPS8000
AXIOM WORLDWIDE, INC. 510(k) NO: K050687(TRADITIONAL)
ATTN: JAMES J GIBSON PHONE NO : 813-249-6444
9423 CORPORATE LAKE DRIVE SE DECISION MADE: 28-JUL-05
TAMPA, FL 33634 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFINION HBALC
AXIS-SHIELD POC AS 510(k) NO: K050574(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751
P.O. BOX 262069 SE DECISION MADE: 22-JUL-05
SAN DIEGO, CA 92196 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANEFIN, MODEL 100
AXON MEDICAL 510(k) NO: K033028(TRADITIONAL)
ATTN: JOSEPH ORR PHONE NO : 801-484-3820
2355 SOUTH 1170 WEST SE DECISION MADE: 22-JUL-05
SUITE D 510(k) SUMMARY AVAILABLE FROM FDA
SALT LAKE CITY, UT 84119
DEVICE: FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT
BARD PERIPHERAL VASCULAR, INC. 510(k) NO: K050832(SPECIAL)
ATTN: DENNIS SALZMANN PHONE NO : 480-303-2780
P.O. BOX 1740 SE DECISION MADE: 07-JUL-05
TEMPE, AZ 85280-1740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MU
BAXTER HEALTHCARE CORP. 510(k) NO: K051253(TRADITIONAL)
ATTN: NANETTE HEDDEN PHONE NO : 847-473-6281
1620 WAUKEGAN ROAD SE DECISION MADE: 15-JUL-05
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647
BECTON DICKINSON & CO. 510(k) NO: K051194(TRADITIONAL)
ATTN: LESLIE WOOD PHONE NO : 801-565-2504
9450 SOUTH STATE STREET SE DECISION MADE: 25-JUL-05
SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD DIRECTIGEN EZ FLU A + B
BECTON, DICKINSON & CO. 510(k) NO: K042472(TRADITIONAL)
ATTN: MICHELLE BYTHEWAY BANDY PHONE NO : 410-316-4778
7 LOVETON CIR. SE DECISION MADE: 07-JUL-05
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.2
BECTON, DICKINSON & CO. 510(k) NO: K051266(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 05-JUL-05
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0
BECTON, DICKINSON & CO. 510(k) NO: K051272(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 11-JUL-05
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0
BECTON, DICKINSON & CO. 510(k) NO: K051692(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 14-JUL-05
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MARROW PLUS (M+)
BERKELEY ADVANCED BIOMATERIALS, IN510(k) NO: K051695(TRADITIONAL)
ATTN: FRANCOIS GENIN PHONE NO : 510-883-0500
901 GRAYSON ST., SUITE 101 SE DECISION MADE: 19-JUL-05
BERKELEY, CA 94710 510(k) STATEMENT
DEVICE: K-C HEMOSTATIC BIOPSY SYSTEM
BIOENGINEERING CONSULTANTS LTD. 510(k) NO: K050135(TRADITIONAL)
ATTN: WILLIAM R KRAUSE PHONE NO : 434-979-4134
801 WEST MAIN STREET SE DECISION MADE: 13-JUL-05
CHARLOTTESVILLE, VA 22903 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIADENT DENTAL IMPLANT SYSTEM
BIOINFERA, INC. 510(k) NO: K043428(ABBREVIATED)
ATTN: CHAN Q WANG PHONE NO : 216-225-2860
21205 HALWORTH ROAD SE DECISION MADE: 12-JUL-05
BEACHWOOD, OH 44122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES
BIOMET, INC. 510(k) NO: K050210(TRADITIONAL)
ATTN: LONNIE WITHAM PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 19-JUL-05
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM
BIOPLATE, INC. 510(k) NO: K051845(SPECIAL)
ATTN: JESUS T FARINAS PHONE NO : 310-815-2100
3643 LENAWEE AVE. SE DECISION MADE: 27-JUL-05
LOS ANGELES, CA 90016-4310 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILAB ULTRASOUND IMAGING SYSTEM
BOSTON SCIENTIFIC CORP. 510(k) NO: K051679(SPECIAL)
ATTN: ROBERT Z PHILLIPS PHONE NO : 510-624-2307
47201 LAKEVIEW BLVD. SE DECISION MADE: 14-JUL-05
FREMONT, CA 94537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
C.R. BARD, INC. 510(k) NO: K051316(TRADITIONAL)
ATTN: JOHN C KNORPP PHONE NO : 770-784-6451
8195 INDUSTRIAL BLVD. SE DECISION MADE: 18-JUL-05
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HAN
CANDELA CORP. 510(k) NO: K051359(TRADITIONAL)
ATTN: LORRAINE CALZETTA PATROVIC PHONE NO : 508-358-7637
530 BOSTON POST RD. SE DECISION MADE: 13-JUL-05
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PMP4 MEDICAL WEB CENTER
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K050940(TRADITIONAL)
ATTN: ALEX GONOROVSKY PHONE NO : 972 894 84600
2 PERERIS ST., SCIENCE PARK SE DECISION MADE: 01-JUL-05
REHOVOT, ISRAEL 76100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORONARY SINUS ACCESS KIT, MODEL KCS8F-01
CARDIO-OPTICS, INC. 510(k) NO: K050808(TRADITIONAL)
ATTN: LARRY BLANKENSHIP PHONE NO : 720-406-1560
2477 55TH ST., SUITE 120 SE DECISION MADE: 28-JUL-05
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMILLUME RED, MODEL HR1000
CARE ELECTRONICS, INC. 510(k) NO: K051681(TRADITIONAL)
ATTN: THOMAS O MOODY PHONE NO : 303-444-2273
4700 STERLING DR., SUITE D SE DECISION MADE: 27-JUL-05
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR
CIBERNET SYSTEMS CORP. 510(k) NO: K050951(TRADITIONAL)
ATTN: ERIC LICHTENSTEIN PHONE NO : 734-668-2567
727 AIRPORT BOULEVARD SE DECISION MADE: 19-JUL-05
ANN ARBOR, MI 48108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS
CLEAR MEDICAL, INC. 510(k) NO: K033578(TRADITIONAL)
ATTN: MIKE KOVACS PHONE NO : 425-401-1414
1776 136TH PL. NE SE DECISION MADE: 11-JUL-05
BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED MULTIPLE CLIP APPLIERS
CLEAR MEDICAL, INC. 510(k) NO: K033579(TRADITIONAL)
ATTN: MIKE KOVACS PHONE NO : 425-401-1414
1776 136TH PL. NE SE DECISION MADE: 11-JUL-05
BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CODMAN VPV SYSTEM, MODEL 82-3192
CODMAN & SHURTLEFF, INC. 510(k) NO: K050739(TRADITIONAL)
ATTN: KAREN F JURCZAK PHONE NO : 508-828-3704
325 PARAMOUNT DR. SE DECISION MADE: 18-JUL-05
RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONMED IRRIGATION NOZZLE
CONMED CORP. 510(k) NO: K050992(TRADITIONAL)
ATTN: IRA DUESLER PHONE NO : 315-624-3072
525 FRENCH RD. SE DECISION MADE: 14-JUL-05
UTICA, NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TURBO-FLO PICC
COOK, INC. 510(k) NO: K041849(TRADITIONAL)
ATTN: EARL E KNIGHT III PHONE NO : 812-339-2235
750 DANIELS WAY PO BX 489 SE DECISION MADE: 21-JUL-05
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZILVER 635 BILIARY STENT
COOK, INC. 510(k) NO: K051124(SPECIAL)
ATTN: STEPHANIE ROBERTS PHONE NO : 800-346-2686
750 DANIELS WAY PO BX 489 SE DECISION MADE: 12-JUL-05
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLFIM IMPLANT SYSTEMS
COWELL MEDI CO LTD. 510(k) NO: K050635(TRADITIONAL)
ATTN: DAE KYU CHANG PHONE NO : 562-404-8466
13340 E. FIRESTONE BLVD. SE DECISION MADE: 28-JUL-05
SUITES J 510(k) SUMMARY AVAILABLE FROM FDA
SANTA FE SPRINGS, CA 90670
DEVICE: CS MEDICAL ADULT TTCF CATHETER
CS MEDICAL INC. 510(k) NO: K050379(TRADITIONAL)
ATTN: LEWIS WARD PHONE NO : 303-530-3279
4655 KIRKWOOD COURT SE DECISION MADE: 12-JUL-05
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CS MEDICAL TTCF GAS DELIVERY SYSTEM
CS MEDICAL INC. 510(k) NO: K050381(TRADITIONAL)
ATTN: LEWIS WARD PHONE NO : 303-530-3279
4655 KIRKWOOD COURT SE DECISION MADE: 13-JUL-05
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO
CURASAN AG, FRANKFURT FACILITY 510(k) NO: K051443(ABBREVIATED)
ATTN: ERIC WIECHERT PHONE NO : 919-772-8518
109 SHORE DRIVE SE DECISION MADE: 22-JUL-05
GARNER, NC 27529 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTECH, MODEL HOLI I
CYCLING AND HEALTH TECH. INDUSTRY 510(k) NO: K050507(TRADITIONAL)
ATTN: CHANG WAN-LAN PHONE NO : 886 4 23501100
NO. 17, 37TH RD. SE DECISION MADE: 07-JUL-05
TAICHUNG INDUSTRY PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN) 40768
DEVICE: LANDLEX MODEL S400X
CYCLING AND HEALTH TECH. INDUSTRY 510(k) NO: K050793(TRADITIONAL)
ATTN: CHANG WAN-LAN PHONE NO : 886 4 23501100
NO. 17, 37TH RD. SE DECISION MADE: 07-JUL-05
TAICHUNG INDUSTRY PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN) 40768
DEVICE: DIMENSION VISTA INTEGRATED SYSTEM
DADE BEHRING, INC. 510(k) NO: K051087(TRADITIONAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6279
P.O. BOX 6101 BLDG 500;M.S.514 SE DECISION MADE: 11-JUL-05
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCEN
DADE BEHRING, INC. 510(k) NO: K051311(TRADITIONAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-374-3183
1584 ENTERPRISE BLVD. SE DECISION MADE: 12-JUL-05
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
DADE BEHRING, INC. 510(k) NO: K051350(TRADITIONAL)
ATTN: ROBERTO EUSEBIO PHONE NO : 916-372-1900
2040 ENTERPRISE BLVD. SE DECISION MADE: 25-JUL-05
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMP
DADE BEHRING, INC. 510(k) NO: K051478(TRADITIONAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-374-3183
1584 ENTERPRISE BLVD. SE DECISION MADE: 27-JUL-05
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: READMYHEART, MODEL RMH3.0
DAILYCARE BIOMEDICAL INC 510(k) NO: K050620(TRADITIONAL)
ATTN: DANIEL J CHANG PHONE NO : 886 3 2621688
8F, 25-3 JI-LIN ROAD SE DECISION MADE: 14-JUL-05
CHUNGLI, CHINA (TAIWAN) 320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XENO ADHESIVE WITH ACTIVATOR
DENTSPLY INTL. 510(k) NO: K051463(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 WEST PHILADELPHIA STREET SE DECISION MADE: 12-JUL-05
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: ECLIPSE BONDING AGENT
DENTSPLY INTL. 510(k) NO: K051707(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 WEST PHILADELPHIA STREET SE DECISION MADE: 15-JUL-05
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: THE ODFS DROPPED FOOT STIMULATOR
DEPARTMENT OF MEDICAL PHYSICS AND 510(k) NO: K050991(TRADITIONAL)
ATTN: TINA LECHMAN PHONE NO : 216-378-9106
ONE CHAGRIN HIGHLANDS SE DECISION MADE: 15-JUL-05
2000 AUBURN DRIVE, SUITE 320 510(k) SUMMARY AVAILABLE FROM FDA
CLEVELAND, OH 44122
DEVICE: EXPEDIUM SPINE SYSTEM
DEPUY SPINE, INC. 510(k) NO: K051024(SPECIAL)
ATTN: SHARON STAROWICZ PHONE NO : 508-828-2867
325 PARAMOUNT DR. SE DECISION MADE: 06-JUL-05
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
DEPUY SPINE,INC 510(k) NO: K043406(TRADITIONAL)
ATTN: SHARON STAROWICZ PHONE NO : 508-828-2867
325 PARAMONT DRIVE SE DECISION MADE: 15-JUL-05
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DCL MICROALBUMIN ASSAY, MODEL 252-20
DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K051191(TRADITIONAL)
ATTN: PENNY WHITE PHONE NO : 902 566 1396
16 MCCARVILLE ST. SE DECISION MADE: 05-JUL-05
CHARLOTTETOWN, P.E.I., CANADA C1E 510(k) STATEMENT
DEVICE: CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
DIGIRAD CORP. 510(k) NO: K051549(SPECIAL)
ATTN: JOEL TUCKEY PHONE NO : 858-726-1600
13950 STOWE DRIVE SE DECISION MADE: 13-JUL-05
POWAY, CA 92064-8803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTEGE ULTRASONIC INSERT
DISCUS DENTAL INC. 510(k) NO: K051776(TRADITIONAL)
ATTN: SUZANNE RIDGWAY PHONE NO : 310-845-8339
8550 HIGUERA ST. SE DECISION MADE: 13-JUL-05
CULVER CITY, CA 90232 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: SKYLIGHT LED CURING LIGHT
DMETEC CO., LTD. 510(k) NO: K051571(TRADITIONAL)
ATTN: CAROLANN KOTULA PHONE NO : 770-985-8203
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 19-JUL-05
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JAUNDICE METER, MODEL JM 103
DRAEGER MEDICAL INFANT CARE, INC. 510(k) NO: K042522(TRADITIONAL)
ATTN: THOMAS M MCINTOSH PHONE NO : 215-682-8634
330 JACKSONVILLE RD. SE DECISION MADE: 06-JUL-05
HATBORO, PA 19040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY MONITORS WITH SCIO MODIFICATIONS
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K051628(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 20-JUL-05
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVITAXL WITH OPTION SMARTCARE
DRAGER MEDICAL AG & CO. KGAA 510(k) NO: K051263(TRADITIONAL)
ATTN: MONICA FERRANTE PHONE NO : 215-721-5400
3135 QUARRY ROAD SE DECISION MADE: 12-JUL-05
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE
DYNATRONICS CORP. 510(k) NO: K051261(TRADITIONAL)
ATTN: RONALD J HATCH PHONE NO : 801-568-7000
7030 PARK CENTRE DR. SE DECISION MADE: 25-JUL-05
SALT LAKE CITY, UT 84121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUMEN IMAGE GUIDED SURGICAL SYSTEM
EBI, L.P. 510(k) NO: K051724(TRADITIONAL)
ATTN: WHITNEY TORNING PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 19-JUL-05
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELEKTA ESARTE FRAME SYSTEM
ELEKTA INSTRUMENT AB 510(k) NO: K051746(SPECIAL)
ATTN: PETER LOWENDAHL PHONE NO : 011 468 58725400
KUNGSTENSGATAN 18 SE DECISION MADE: 25-JUL-05
P.O.BOX 7593 510(k) SUMMARY AVAILABLE FROM FDA
STOCKHOLM, SWEDEN S-103 93
DEVICE: COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES
EMG TECHNOLOGY CO., LTD. 510(k) NO: K043238(ABBREVIATED)
ATTN: LEONARD FRIER PHONE NO : 410-354-3300
914 WEST PATAPSCO AVE. SE DECISION MADE: 06-JUL-05
BALTIMORE, MD 21230 510(k) STATEMENT
DEVICE: ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES
ERBE USA, INC. 510(k) NO: K051509(TRADITIONAL)
ATTN: JULIE STEPHENS PHONE NO : 678-513-0693
111 LAUREL RIDGE DRIVE SE DECISION MADE: 27-JUL-05
ALPHARETTA, GA 30004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100
ESAOTE, S.P.A. 510(k) NO: K051837(TRADITIONAL)
ATTN: CARRI GRAHAM PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE SE DECISION MADE: 20-JUL-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERRAQUANT MQ2000 LASER THERAPY DEVICE
ESCADA INTERNATIONAL, INC. 510(k) NO: K043055(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 25-JUL-05
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-PLATE ANTERIOR FIXATION SYSTEM
ESM TECHNOLOGIES 510(k) NO: K051764(TRADITIONAL)
ATTN: CLIFF TRIBUS PHONE NO : 608-332-8521
403 FARWELL DRIVE SE DECISION MADE: 13-JUL-05
MADISON, WI 53704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEALIGHT IPL
EUROPRO, INC. 510(k) NO: K043032(TRADITIONAL)
ATTN: GREG KENNEBECK PHONE NO : 800-272-1716
3952 CAMINO RANCHERO RD. SE DECISION MADE: 19-JUL-05
CAMARILLO, CA 93012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPAD
EURORESEARCH S.R.L. 510(k) NO: K040283(TRADITIONAL)
ATTN: E. SMITH PHONE NO : 410-451-0639
1468 HARWELL AVENUE SE DECISION MADE: 22-JUL-05
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSPIRATION VENTILATOR SYSTEM
EVENT MEDICAL LTD. 510(k) NO: K051550(SPECIAL)
ATTN: ROBBIE WALSH PHONE NO : 353 917 64472
6A LIOSBAN BUSINESS PARK SE DECISION MADE: 12-JUL-05
TUAM ROAD 510(k) SUMMARY AVAILABLE FROM FDA
GALWAY, IRELAND
DEVICE: DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR
EVER GLOBAL ENTERPRISE CORPORATION510(k) NO: K051393(ABBREVIATED)
ATTN: NICK BIEN PHONE NO : 886 266 003630
LONG THANH INDUSTRIAL ZONE SE DECISION MADE: 27-JUL-05
TAMAN VILLAGE, LONG THANH 510(k) SUMMARY AVAILABLE FROM FDA
DIST., DONG NAI PROVINCE, VIETNAM
DEVICE: DISPOSABLE POWDERED VINYL EXAM GLOVE YELLOW COLOR
EVER GLOBAL ENTERPRISE CORPORATION510(k) NO: K051498(TRADITIONAL)
ATTN: NICK BIEN PHONE NO : 886 266 003630
LONG THANH INDUSTRIAL ZONE SE DECISION MADE: 06-JUL-05
TAMAN VILLAGE, LONG THANH 510(k) SUMMARY AVAILABLE FROM FDA
DIST., DONG NAI PROVINCE, VIETNAM
DEVICE: EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM
EXACTECH, INC. 510(k) NO: K051682(SPECIAL)
ATTN: MARITZA ELIAS PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 19-JUL-05
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR T
FIRST QUALITY HYGIENIC INC. 510(k) NO: K051446(TRADITIONAL)
ATTN: ROBERT J STAAB PHONE NO : 201-327-0035
73 FRANKLIN TPK SE DECISION MADE: 14-JUL-05
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VP WIRE GW140ST (.014" 165CM, STANDAR), MODEL GW140ST; VP WIRE G
FLOWCARDIA, INC. 510(k) NO: K051062(TRADITIONAL)
ATTN: RICHARD SPANO PHONE NO : 408-617-0352
745 N. PASTORIA AVE. SE DECISION MADE: 15-JUL-05
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJI SYNAPSE WORKSTATION SOFTWARE
FUJIFILM MEDICAL SYSTEMS USA, INC.510(k) NO: K051553(TRADITIONAL)
ATTN: ROBERT BERRY PHONE NO : 203-602-3753
419 WEST AVENUE SE DECISION MADE: 07-JUL-05
STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NATURE-CRYL HI PLUS
GC AMERICA, INC. 510(k) NO: K051358(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 07-JUL-05
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION
GE HEALTHCARE 510(k) NO: K051634(SPECIAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 19-JUL-05
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND AC
GE HEALTHCARE 510(k) NO: K051635(SPECIAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 15-JUL-05
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XELERIS 2 PROCESSING AND REVIEW WORKSTATION
GE MEDICAL SYSTEMS 510(k) NO: K051673(SPECIAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 N GRANDVIEW BLVD. SE DECISION MADE: 18-JUL-05
W-709 510(k) SUMMARY AVAILABLE FROM FDA
WAUKESHA, WI 53188
DEVICE: MARS HOLTER ANALYSIS WORKSTATION
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K051026(TRADITIONAL)
ATTN: LISA M BAUMHARDT PHONE NO : 262-293-1699
8200 WEST TOWER AVE. SE DECISION MADE: 19-JUL-05
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNITY NETWORK ID
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K051518(SPECIAL)
ATTN: RONALD N BLASKI PHONE NO : 414-362-2348
8200 WEST TOWER AVE. SE DECISION MADE: 08-JUL-05
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE OEC EVERVIEW 7500
GE OEC MEDICAL SYSTEMS, INC. 510(k) NO: K051490(TRADITIONAL)
ATTN: SUSAN SCHMIDT PHONE NO : 801-328-9300
384 WRIGHT BROTHERS DR. SE DECISION MADE: 07-JUL-05
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEPRAGEL ENT BIORESORBABLE PACKING/STENT
GENZYME CORPORATION 510(k) NO: K043035(TRADITIONAL)
ATTN: BARBARA PIZZA PHONE NO : 617-252-7953
55 CAMBRIDGE PARKWAY SE DECISION MADE: 11-JUL-05
CAMBRIDGE, MA 02142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOMEM CM 3000-12
GETEMED MEDIZIN- UND INFORMATIONST510(k) NO: K051686(ABBREVIATED)
ATTN: CAROLANN KOTULA PHONE NO : 770-985-8203
55 NORTHERN BLVD SE DECISION MADE: 14-JUL-05
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
GLOBUS MEDICAL, INC. 510(k) NO: K050391(TRADITIONAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000
303 SCHELL LANE SE DECISION MADE: 21-JUL-05
PHOENIXVILLE, PA 19460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT
GOODMARK USA, INC. 510(k) NO: K051668(TRADITIONAL)
ATTN: ROBERT J MICHALIK PHONE NO :
12 BLENDON WOODS DRIVE SE DECISION MADE: 08-JUL-05
SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR)
GRAND WORK PLASTIC PRODUCTS CO., L510(k) NO: K051662(TRADITIONAL)
ATTN: MICKY LIN PHONE NO : 909-591-7888
3973 SCHAFER AVE. SE DECISION MADE: 22-JUL-05
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLARIS NON-STICK BIPOLAR FORCEPS
GUENTER BISSINGER MEDIZINTECHNIK G510(k) NO: K051429(TRADITIONAL)
ATTN: CHRISTA HEITMANN-FRANKE PHONE NO : 602-758-1029
ONE PARK AVE., SUITE #5G SE DECISION MADE: 29-JUL-05
HAMPTON, NH 03842 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIRAMATIC SAFE SYRINGE SYSTEM
HAGER WORLDWIDE, INC. 510(k) NO: K043322(TRADITIONAL)
ATTN: JAMES DELANEY PHONE NO : 978-475-5692
4 LINCOLN ST SE DECISION MADE: 21-JUL-05
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SHOULDER FIXATION SYSTEM
HAND INNOVATIONS, LLC. 510(k) NO: K051728(SPECIAL)
ATTN: ERNESTO HERNANDEZ PHONE NO : 305-270-6899
8905 SW 87TH AVENUE SE DECISION MADE: 20-JUL-05
SUITE 220 510(k) SUMMARY AVAILABLE FROM FDA
MIAMI, FL 33176
DEVICE: HANS HERMANN LAPAROSCOPES AND ACCESSORIES
HANS HERMANN GMBH 510(k) NO: K051610(TRADITIONAL)
ATTN: HARALD JUNG PHONE NO : 49 746 1969236
UNTERER WINKEL 3 SE DECISION MADE: 29-JUL-05
WURMLINGEN, GERMANY D-78567 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BOSWORTH SEAL
HARRY J. BOSWORTH CO. 510(k) NO: K051224(TRADITIONAL)
ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400
7227 NORTH HAMLIN AVE. SE DECISION MADE: 28-JUL-05
SKOKIE, IL 60076 510(k) STATEMENT
DEVICE: NITRILE POWDERED EXAMINATION GLOVES (BLUE)
HARTALEGA SDN BHD 510(k) NO: K051778(TRADITIONAL)
ATTN: KUAN KAM HON PHONE NO : 603 627 42177
9 JALAN KUANG BULAN TAMAN SE DECISION MADE: 26-JUL-05
KEPONG INDUSTRIAL ESTATE 510(k) STATEMENT
KUALA LUMPUR, MALAYSIA 52100
DEVICE: HEMORAM/AGGRAM ANALYZER
HELENA LABORATORIES 510(k) NO: K050053(TRADITIONAL)
ATTN: PATRICIA FRANKS PHONE NO : 409-842-3714
1530 LINDBERGH DR. SE DECISION MADE: 11-JUL-05
P.O. BOX 752 510(k) STATEMENT
BEAUMONT, TX 77704
DEVICE: PALACOS LV+G
HERAEUS KULZER GMBH 510(k) NO: K050854(TRADITIONAL)
ATTN: CHRISTIAN TUCHSCHERER PHONE NO : 49 608 1959278
PHILLIP REIS-STRASSE 8/13 SE DECISION MADE: 07-JUL-05
WEHRHEIM, GERMANY D-61273 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALAMED G
HERAEUS KULZER GMBH 510(k) NO: K050855(TRADITIONAL)
ATTN: CHRISTIAN TUCHSCHERER PHONE NO : 496 081 959287
PHILLIP REIS-STRASSE 8/13 SE DECISION MADE: 07-JUL-05
WEHRHEIM, GERMANY D-61273 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIDEKICK BLOOD GLUCOSE TEST SYSTEM
HOME DIAGNOSTICS, INC. 510(k) NO: K051147(SPECIAL)
ATTN: KAREN DEVINCENT PHONE NO : 954-677-9201
2400 N.W. 55TH CT. SE DECISION MADE: 12-JUL-05
FORT LAUDERDALE, FL 33309 510(k) STATEMENT
DEVICE: TRIATHLON KNEE SYSTEM
HOWMEDICA OSTEONICS CORP 510(k) NO: K051146(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
325 CORPORATE DR. SE DECISION MADE: 13-JUL-05
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOLOX DELTA CERAMIC FEMORAL HEADS
HOWMEDICA OSTEONICS CORP 510(k) NO: K051588(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
325 CORPORATE DR. SE DECISION MADE: 12-JUL-05
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2 RECON NAIL SYSTEM
HOWMEDICA OSTEONICS CORP 510(k) NO: K051624(SPECIAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
325 CORPORATE DR. SE DECISION MADE: 07-JUL-05
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE
HOWMEDICA OSTEONICS CORP 510(k) NO: K051737(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
325 CORPORATE DR. SE DECISION MADE: 19-JUL-05
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECUR-FIT MAX AND PLUS MAX HIP STEMS
HOWMEDICA OSTEONICS CORP 510(k) NO: K051738(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
325 CORPORATE DR. SE DECISION MADE: 19-JUL-05
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2 ANKLE ARTHRODESIS NAIL
HOWMEDICA OSTEONICS CORP. 510(k) NO: K051590(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
325 CORPORATE DRIVE SE DECISION MADE: 29-JUL-05
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026
HWANG SUN ENTERPRISE CO., LTD. 510(k) NO: K050410(TRADITIONAL)
ATTN: SING-HONG YEUNG PHONE NO : 631-924-2751
11 HEATHER COURT SE DECISION MADE: 14-JUL-05
MIDDLE ISLAND, NY 11953 510(k) STATEMENT
DEVICE: EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND
HYDROGEL VISION CORPORATION 510(k) NO: K051430(TRADITIONAL)
ATTN: DONNA HOVANEC PHONE NO : 941-739-1382
7575 COMMERCE COURT SE DECISION MADE: 18-JUL-05
SARASOTA, FL 34243 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUMERAL HEAD PLATE WITH ANGULAR STABILITY
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTE510(k) NO: K051412(TRADITIONAL)
ATTN: AL LIPPINCOTT PHONE NO : 952-492-5858
3150 E. 200TH ST. SE DECISION MADE: 11-JUL-05
PRIOR LAKE, MN 55372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1,25-DIHYDROXY VITAMIN D EIA
IMMUNODIAGNOSTIC SYSTEMS LTD. 510(k) NO: K051110(ABBREVIATED)
ATTN: PAUL PUNTIN PHONE NO : +44 191 5190660
10 DIDCOT WAY, SE DECISION MADE: 06-JUL-05
BOLDEN BUSINESS PARK 510(k) STATEMENT
BOLDON, TYNE & WEAR, UNITED KINGDOM NE35 9PD
DEVICE: IMPEDIMED - BODY COMPOSITION ANALYSIS
IMPEDIMED PTY LTD. 510(k) NO: K050395(TRADITIONAL)
ATTN: NEVELLI BERTWISTLE PHONE NO : 617 342 31777
BUILDING 4B/2404 LOGAN ROAD SE DECISION MADE: 13-JUL-05
EIGHT MILE PLAINS 510(k) SUMMARY AVAILABLE FROM FDA
BRISBANE, QUEENSLAND, AUSTRALIA 4113
DEVICE: RN SYNOCTA TEMPORARY MESO ABUTMENT
INSTITUT STRAUMANN SA 510(k) NO: K051717(SPECIAL)
ATTN: LINDA JALBERT PHONE NO : 800-448-8168
60 MINUTEMAN ROAD SE DECISION MADE: 07-JUL-05
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRALASE FS LASER
INTRALASE CORP. 510(k) NO: K041893(TRADITIONAL)
ATTN: CHARLINE GAUTHIER PHONE NO : 949-859-5230
9701 JERONIMO ROAD SE DECISION MADE: 29-JUL-05
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAGRAFT II DENTAL
ISOTIS ORTHOBIOLOGICS, INC 510(k) NO: K043573(TRADITIONAL)
ATTN: PAUL DONER PHONE NO : 949-855-7168
2 GOODYEAR, SUITE B SE DECISION MADE: 29-JUL-05
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONNEXUS
ISOTIS ORTHOBIOLOGICS, INC 510(k) NO: K050690(TRADITIONAL)
ATTN: PAUL DONER PHONE NO : 949-855-7168
2 GOODYEAR, SUITE B SE DECISION MADE: 07-JUL-05
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JETLITE 5000
J. MORITA USA, INC. 510(k) NO: K051780(TRADITIONAL)
ATTN: HOWARD ROWE PHONE NO : 949-465-1034
9 MASON SE DECISION MADE: 28-JUL-05
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321
K-JUMP HEALTH CO., LTD. 510(k) NO: K051365(ABBREVIATED)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORHTERN BLVD. SE DECISION MADE: 22-JUL-05
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALEUTIAN SPACER SYSTEM
K2M, LLC 510(k) NO: K051454(TRADITIONAL)
ATTN: RICH WOODS PHONE NO : 703-777-3155
751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 27-JUL-05
LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: L.E. DEMETRON II
KERR CORPORATION (DANBURY) 510(k) NO: K051545(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVE. SE DECISION MADE: 18-JUL-05
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIRECT DIGITIZER REGIUS MODEL 370
KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K051418(SPECIAL)
ATTN: SHINICHI MAMANAKA PHONE NO : 815 963 70190
319 AKENO, OBATA-CHO SE DECISION MADE: 01-JUL-05
WATARAI-GUN 510(k) STATEMENT
MIE-KEN, JAPAN 519-05
DEVICE: REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE
KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K051523(TRADITIONAL)
ATTN: SHINICHI YAMANAKA PHONE NO : 815 963 70190
319 AKENO, OBATA-CHO SE DECISION MADE: 20-JUL-05
WATARAI-GUN, MIE-KEN, JAPAN 519-05510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVANTICARE, MODEL SA4022
LERADO CHINA LIMITED 510(k) NO: K051538(TRADITIONAL)
ATTN: JEFF CHANG PHONE NO : 886 422 465396
CHONGDE RD., BEITUN DISTRICT SE DECISION MADE: 21-JUL-05
TAICHUNG, CHINA (TAIWAN) 40653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TESLAOXYSAT, MODEL EFOXYSATE
MAMMENDORFER INSTITUTE FOR PHYSICS510(k) NO: K050018(TRADITIONAL)
ATTN: ROBERT N CLARK PHONE NO : 303-234-9412
13605 WEST 7TH AVE. SE DECISION MADE: 01-JUL-05
GOLDEN, CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VE
MARIAN MEDICAL, INC. 510(k) NO: K050542(TRADITIONAL)
ATTN: SANDRA WINKLER PHONE NO : 502-552-6189
319 WESTPORT DR. SE DECISION MADE: 26-JUL-05
LOUISVILLE, KY 40207 510(k) STATEMENT
DEVICE: MODIFICATION TO LNCS OXIMETRY SENSORS
MASIMO CORPORATION 510(k) NO: K051212(SPECIAL)
ATTN: JAMES J CRONIN PHONE NO : 949-297-7000
40 PARKER SE DECISION MADE: 12-JUL-05
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LNOP BLUE OXIMETRY SENSOR
MASIMO CORPORATION 510(k) NO: K051439(TRADITIONAL)
ATTN: JAMES J CRONIN PHONE NO : 949-297-7000
40 PARKER SE DECISION MADE: 15-JUL-05
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITAL SIGNS MONITOR
MEDIANA CO., LTD. 510(k) NO: K051375(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931-937-8093
340 SHADY GROVE ROAD SE DECISION MADE: 28-JUL-05
FLINTVILLE, TN 37335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDICINELODGE ZIPKNOT
MEDICINELODGE, INC. 510(k) NO: K051488(TRADITIONAL)
ATTN: M. MRY SINNOTT PHONE NO : 435-753-7675
180 SOUTH 600 WEST SE DECISION MADE: 27-JUL-05
LOGAN, UT 84321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHOSYSTEM
MEDSTRAT, INC. 510(k) NO: K051745(ABBREVIATED)
ATTN: ROBERT J BISHOP PHONE NO : 630-960-8700
1901 BUTTERFIELD RD. SE DECISION MADE: 14-JUL-05
SUITE 600 510(k) SUMMARY AVAILABLE FROM FDA
DOWNERS GROVE, IL 60515 THIRD PARTY REVIEW
DEVICE: MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEA
MEDTRONIC INC.,NEUROLOGICAL DIVISI510(k) NO: K051773(SPECIAL)
ATTN: PAULA CORDERO PHONE NO : 763-505-0238
710 MEDTRONIC PKWY. SE DECISION MADE: 28-JUL-05
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION
MEDTRONIC NAVIGATION, INC. 510(k) NO: K050651(TRADITIONAL)
ATTN: TINA DREILING PHONE NO : 720-890-3217
826 COAL CREEK CIRCLE SE DECISION MADE: 27-JUL-05
LOUSVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K051674(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 21-JUL-05
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MS 9/5 HEMATOLOGY ANALYZER
MELET SCHLOESING LABORATORIES USA 510(k) NO: K050436(ABBREVIATED)
ATTN: JACKIE COLEMAN PHONE NO : 858-268-8165
7703 CONVOY CT SE DECISION MADE: 27-JUL-05
SAN DIEGO, CA 92111 510(k) STATEMENT
DEVICE: MERETE TWISTCUT SNAP-OFF BONE SCREW
MERETE MEDICAL GMBH 510(k) NO: K051323(TRADITIONAL)
ATTN: EMMANUEL ANAPLIOTIS PHONE NO : 212-496-2700
269 WEST SEVENTY-FIRST STREET SE DECISION MADE: 07-JUL-05
NEW YORK, NY 10023 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEVIS LIVERANALYSER/LIVERVIEWER SOFTWARE
MEVIS TECHNOLOGY GMBH & CO. KG 510(k) NO: K051528(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 20-JUL-05
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICK HDR INTERSTITIAL IMPLANT ACCESSORIES
MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K051423(TRADITIONAL)
ATTN: FELIX MIOK PHONE NO : 914-667-3999
521 HOMESTEAD AVE. SE DECISION MADE: 01-JUL-05
MOUNT VERNON, NY 10550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MILTEX RIGID STERILIZATION CONTAINER SYSTEM
MILTEX, INC. 510(k) NO: K050570(TRADITIONAL)
ATTN: LEE ZAGAR PHONE NO : 717-840-3416
589 DAVIES DRIVE SE DECISION MADE: 25-JUL-05
YORK, PA 17402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIROTEL
MIR MEDICAL INTL. RESEARCH SRL 510(k) NO: K043528(TRADITIONAL)
ATTN: SIMON FOWLER PHONE NO : 39 062 2754777
VIA DEL MAGGIOLINO 125 SE DECISION MADE: 19-JUL-05
ROMA, ITALY 00155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARRIER SURGICAL DRAPES
MOLNLYCKE HEALTH CARE, INC. 510(k) NO: K051625(SPECIAL)
ATTN: JOHN CLAY PHONE NO : 267-685-2078
826 NEWTOWN-YARDLEY RD. SE DECISION MADE: 14-JUL-05
NEWTOWN, PA 18940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODE
MULTIGON INDUSTRIES, INC. 510(k) NO: K051739(TRADITIONAL)
ATTN: WILLIAM STERN PHONE NO : 914-376-5200
ONE ODELL PLAZA SE DECISION MADE: 28-JUL-05
YONKERS, NY 10701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFT
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K042125(TRADITIONAL)
ATTN: KAREN HARDWICK PHONE NO : 732-661-2354
125 MAY STREET SE DECISION MADE: 28-JUL-05
EDISON, NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3TEST GLUCOSE MONITORING SYSTEM
NEUERO ENGINEERING INC. 510(k) NO: K050224(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO 58, FU-CHIUN STREET SE DECISION MADE: 13-JUL-05
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERETOM, MODEL NL3000
NEUROLOGICA CORPORATION 510(k) NO: K051765(TRADITIONAL)
ATTN: BRAHIM HADRI PHONE NO : 978-564-8500
14 ELECTRONICS AVENUE SE DECISION MADE: 14-JUL-05
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EV
NEURORECOVERY, INC. 510(k) NO: K051599(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 19-JUL-05
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOBELREPLACE ADAPTER, MODEL 32412
NOBEL BIOCARE USA, INC. 510(k) NO: K050444(TRADITIONAL)
ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800
22715 SAVI RANCH PKWY. SE DECISION MADE: 07-JUL-05
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC
NOBLE FIBER TECHNOLOGIES, INC. 510(k) NO: K051256(TRADITIONAL)
ATTN: WILLIAM F MCNALLY PHONE NO : 877-978-2842
421 SOUTH STATE ST. SE DECISION MADE: 21-JUL-05
CLARKS SUMMIT, PA 18411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIGATOR
NOMOS CORP. 510(k) NO: K042875(TRADITIONAL)
ATTN: LEIGH SPOTTEN PHONE NO : 818-734-8600
200 WEST KENSINGER DR. SE DECISION MADE: 01-JUL-05
CRANBERRY TOWNSHIP, PA 16066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORWOOD ABBEY CENTURION SES EPIKERATOME
NORWOOD ABBEY , LTD. 510(k) NO: K051486(SPECIAL)
ATTN: PAUL CLARK PHONE NO : 613 978 27308
63 WELLS RD. SE DECISION MADE: 06-JUL-05
CHELSEA HGTS., VICTORIA, AUSTRALIA510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUBER CLEAR SAFETY INFUSION SET
NOW MEDICAL DISTRIBUTION, INC. 510(k) NO: K051009(TRADITIONAL)
ATTN: CHRISTINE EMANNUEL PHONE NO : 805-963-4312
1205 DE LA VINA STREET SE DECISION MADE: 12-JUL-05
SANTA BARBARA, CA 93101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIB PTA BALLOON CATHETER
NUMED, INC. 510(k) NO: K050857(TRADITIONAL)
ATTN: JODI GIJANTO PHONE NO : 315-328-4491
2880 MAIN ST. SE DECISION MADE: 28-JUL-05
HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINI GHOST PTA CATHETER, MODEL 507
NUMED, INC. 510(k) NO: K051343(SPECIAL)
ATTN: NICHELLE LAFLESH PHONE NO : 315-328-4491
2880 MAIN ST. SE DECISION MADE: 28-JUL-05
HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM
NUVASIVE, INC. 510(k) NO: K051384(SPECIAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868
4545 TOWNE CENTRE CT. SE DECISION MADE: 11-JUL-05
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GF-UE160-AL5 ULTRASOUND ENDOSCOPE
OLYMPUS AMERICA, INC. 510(k) NO: K051541(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DR. SE DECISION MADE: 01-JUL-05
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SINGLE USE BALLOON DILATOR MAXPASSTM
OLYMPUS WINTER & IBE GMBH 510(k) NO: K050502(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DR. SE DECISION MADE: 08-JUL-05
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EYE-CEPT REWETTING DROPS
OPTICS LABORATORY, INC. 510(k) NO: K041008(TRADITIONAL)
ATTN: J.R. CHEN PHONE NO : 318-635-1594
5408 INTERSTATE DRIVE SE DECISION MADE: 01-JUL-05
SHREVEPORT, LA 71109 510(k) STATEMENT
DEVICE: LUMIPHASE-R
OPUSMED INC. 510(k) NO: K051255(TRADITIONAL)
ATTN: IAN GORDON PHONE NO : 727-797-4727
2454 MCMULLEN BOOTH ROAD SE DECISION MADE: 01-JUL-05
SUITE 427 510(k) SUMMARY AVAILABLE FROM FDA
CLEARWATER, FL 33759
DEVICE: BIORESORB MACRO PORE
ORALTRONICS DENTAL IMPLANT TECHNOL510(k) NO: K050260(TRADITIONAL)
ATTN: CHAD BARTEE PHONE NO : 806-796-1923
3234 64TH ST. SE DECISION MADE: 15-JUL-05
LUBBOCK, TX 79413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIVOT BIPOLAR FEMORAL HEAD
ORTHO DEVELOPMENT CORP. 510(k) NO: K050966(TRADITIONAL)
ATTN: WILLIAM J GRIFFIN PHONE NO : 801-553-9991
12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 07-JUL-05
DRAPER, UT 84020 510(k) STATEMENT
DEVICE: EQUA-PULL SAFETY RELEASE MODULE
ORTHO TECHNOLOGY 510(k) NO: K051751(TRADITIONAL)
ATTN: STEVE KLAMIC PHONE NO : 813-991-5896
17401 COMMERCE PARK BOULEVARD SE DECISION MADE: 22-JUL-05
TAMPA, FL 33647 510(k) STATEMENT
DEVICE: GENEROS SB SMALL BONE DISTRACTION IMPLANT
ORTHONETX, INC. 510(k) NO: K051162(TRADITIONAL)
ATTN: TERRY KNAPP PHONE NO : 303-494-1681
1000 S. MACCASLIN BLVD. SE DECISION MADE: 19-JUL-05
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
SUPERIOR, CO 80027
DEVICE: OSCAR, MODEL OE3000DB
ORTHOSONICS, LTD. 510(k) NO: K051053(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-570-0013
2305 GOLD MINE RD. SE DECISION MADE: 21-JUL-05
BROOKEVILLE, MD 20833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCAN300FP / RETROPAN (VDC)
OY AJAT, LTD. 510(k) NO: K051664(TRADITIONAL)
ATTN: CLAUDE D BERTHOIN PHONE NO : 386-672-0450
110 E GRANADA BLVD. SUITE 207 SE DECISION MADE: 20-JUL-05
ORMOND BEACH, FL 32176 510(k) STATEMENT
DEVICE: POWDERED LATEX PATIENT EXAMINATION GLOVES
P.T. ANLIS ABADI INTERNASIONAL 510(k) NO: K051465(TRADITIONAL)
ATTN: HUAN-CHUNG LI PHONE NO : 978-436-9980
17A STERLING ROAD SE DECISION MADE: 12-JUL-05
NORTH BILLERICA, MA 01862 510(k) STATEMENT
DEVICE: THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 IN
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K051106(SPECIAL)
ATTN: HAUKE SCHIK PHONE NO : +49 703 14632031
HEWLETT-PACKARD STR.2 SE DECISION MADE: 01-JUL-05
BOEBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT SCENTED (
PLATINUM GLOVE INDUSTRIES SDN.BHD.510(k) NO: K051372(TRADITIONAL)
ATTN: SO SOON CHEAW PHONE NO : 603 214 44215
4015A, FL 4,PRESIDENT HSE, SE DECISION MADE: 07-JUL-05
JLN SULTAN ISMAIL 510(k) STATEMENT
KUALA LUMPUR, MALAYSIA 50250
DEVICE: POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES
PT. MEDISAFE TECHNOLOGIES 510(k) NO: K050968(TRADITIONAL)
ATTN: ANIL TANEJA PHONE NO : 620 617 941493
JL.BATANG KUIS GG.TAMBAK REJO SE DECISION MADE: 12-JUL-05
DESA BUNTU BEDIMBAR TJ. MORAWA 510(k) STATEMENT
MEDAN, NORTH SUMATERA, INDONESIA 20362
DEVICE: LTV 1000 VENTILATOR
PULMONETIC SYSTEMS, INC. 510(k) NO: K051767(SPECIAL)
ATTN: ROBERT C SAMEC PHONE NO : 763-398-8305
17400 MEDINA ROAD SE DECISION MADE: 29-JUL-05
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55447
DEVICE: QUANTUM VERTEBRAL BODY REPLACEMENT
QUANTUM ORTHOPEDICS, INC. 510(k) NO: K050449(TRADITIONAL)
ATTN: JASON BLAIN PHONE NO : 760-607-0121
2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 07-JUL-05
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES)
QUEST DIAGNOSTICS, INC. 510(k) NO: K042725(TRADITIONAL)
ATTN: JAMES A BOURLAND PHONE NO : 702-733-3769
4230 BURNHAM AVE. SE DECISION MADE: 06-JUL-05
LAS VEGAS, NV 89119-5410 510(k) STATEMENT
DEVICE: QUEST DIAGNOSTICS HAIRCHECK-DT (PCP
QUEST DIAGNOSTICS, INC. 510(k) NO: K042726(TRADITIONAL)
ATTN: JAMES A BOURLAND PHONE NO : 702-733-3769
4230 BURNHAM AVE. SE DECISION MADE: 28-JUL-05
LAS VEGAS, NV 89119-5410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL
R & D SYSTEMS, INC. 510(k) NO: K051339(SPECIAL)
ATTN: RALPH E HOGANCAMP PHONE NO : 612-656-4413
614 MCKINLEY PL., N.E. SE DECISION MADE: 12-JUL-05
MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R2 BREAST IMAGING WORKSTATION
R2 TECHNOLOGY, INC. 510(k) NO: K051743(TRADITIONAL)
ATTN: DENISE F GOTTFRIED PHONE NO : 408-481-5646
1195 WEST FREMONT AVE. SE DECISION MADE: 25-JUL-05
SUNNYVALE, CA 94087 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT
RADIANCY, LTD. 510(k) NO: K051268(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 13TH ST. NW SE DECISION MADE: 06-JUL-05
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROI FUSION RODS & PLATES
REILEY ORTHOPAEDICS, INC. 510(k) NO: K051309(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 11-JUL-05
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRAXEL SR LASER SYSTEM
RELIANT TECHNOLOGIES, INC. 510(k) NO: K050841(TRADITIONAL)
ATTN: HEATHER TANNER PHONE NO : 650-473-0200
260 SHERIDAN AVE. SE DECISION MADE: 05-JUL-05
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
PALO ALTO, CA 94306
DEVICE: RES TRAXX DATA CENTER
RESMED LTD. 510(k) NO: K051314(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 15-JUL-05
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000
RESPIRONICS CALIFORNIA, INC. 510(k) NO: K051262(TRADITIONAL)
ATTN: MARY FUNK PHONE NO : 760-918-7300
2271 COSMOS CT. SE DECISION MADE: 08-JUL-05
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
ROCHE DIAGNOSTICS 510(k) NO: K051752(SPECIAL)
ATTN: THERESA M AMBROSE PHONE NO : 317-521-3544
9115 HAGUE ROAD SE DECISION MADE: 11-JUL-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET
ROCHE DIAGNOSTICS CORP. 510(k) NO: K050231(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317-521-3544
9115 HAGUE RD. SE DECISION MADE: 06-JUL-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS CA 19-9 CALCHECK
ROCHE DIAGNOSTICS CORP. 510(k) NO: K051185(TRADITIONAL)
ATTN: CORINA HARPER PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 06-JUL-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS PRECICONTROL ANEMIA
ROCHE DIAGNOSTICS CORP. 510(k) NO: K051517(TRADITIONAL)
ATTN: CORNIA HARPER PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 05-JUL-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS PRECICONTROL UNIVERSAL
ROCHE DIAGNOSTICS CORP. 510(k) NO: K051687(TRADITIONAL)
ATTN: CORINA HARPER PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 25-JUL-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN
SALIMETRICS LLC. 510(k) NO: K051012(TRADITIONAL)
ATTN: VIRGINIA MCKAY MCKAY PHONE NO : 814-234-7748
101 INNOVATION BLVD. SUITE 302 SE DECISION MADE: 19-JUL-05
STATE COLLEGE, PA 16803-6605 510(k) STATEMENT
DEVICE: SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000
SANARUS MEDICAL, INC. 510(k) NO: K051581(TRADITIONAL)
ATTN: TRENA DEPEL PHONE NO : 925-460-6080
4696 WILLOW RD. SE DECISION MADE: 27-JUL-05
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFETY NEEDLE
SARSTEDT, INC. 510(k) NO: K051019(TRADITIONAL)
ATTN: PETER RUMSWINKEL PHONE NO : 828-465-4000
1025 ST. JAMES CHURCH RD. SE DECISION MADE: 25-JUL-05
NEWTON, NC 28658 510(k) STATEMENT
DEVICE: WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA),
SCANTIBODIES LABORATORY, INC. 510(k) NO: K051141(TRADITIONAL)
ATTN: MICHAEL NORDSTROM PHONE NO : 619-258-9300
9336 ABRAHAM WAY SE DECISION MADE: 26-JUL-05
SANTEE, CA 92071 510(k) STATEMENT
DEVICE: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
SCANTIBODIES LABORATORY, INC. 510(k) NO: K051150(TRADITIONAL)
ATTN: MICHAEL NORDSTROM PHONE NO : 619-258-9300
9336 ABRAHAM WAY SE DECISION MADE: 26-JUL-05
SANTEE, CA 92071 510(k) STATEMENT
DEVICE: MALIBU SPINAL SYSTEM
SEASPINE, INC. 510(k) NO: K051663(TRADITIONAL)
ATTN: DIANA SMITH PHONE NO : 760-727-8399
2303 LA MIRADA DR. SE DECISION MADE: 12-JUL-05
VISTA, CA 92081-7862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALIBU SPINAL SYSTEM
SEASPINE, INC. 510(k) NO: K051942(TRADITIONAL)
ATTN: DIANA SMITH PHONE NO : 760-727-8399
2302 LA MIRADA DRIVE SE DECISION MADE: 27-JUL-05
VISTA, CA 92081-7862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENTINEL PLASMAPROTEINS CAL 3X
SENTINEL CH. SRL 510(k) NO: K051457(ABBREVIATED)
ATTN: DAVIDE SPADA PHONE NO : 39 02 3455141
5 VIA PRINCIPE EUGENIO SE DECISION MADE: 25-JUL-05
MILANO, ITALY 20155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TISSU-TRANS
SHIPPERT MEDICAL TECHNOLOGIES CORP510(k) NO: K050797(TRADITIONAL)
ATTN: SARAH LAKE PHONE NO : 303-754-0044
6248 SOUTH TROY CIRCLE SE DECISION MADE: 13-JUL-05
UNIT A 510(k) STATEMENT
CENTENNIAL, CO 80111
DEVICE: NITRILE EXAMINATION GLOVES, POWDER FREE
SHUN THAI RUBBER GLOVES INDUSTRY C510(k) NO: K051333(TRADITIONAL)
ATTN: ANAN JETSADAWISUT PHONE NO : 662 274 0550
238/1 RATCHADA-PISEK ROAD SE DECISION MADE: 22-JUL-05
HUAY-KWANG, BANGKOK 10310 510(k) STATEMENT
THAILAND, THAILAND
DEVICE: STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATIN
SIAM SEMPERMED CORP. LTD. 510(k) NO: K051329(ABBREVIATED)
ATTN: WILLIAM E HARRIS PHONE NO : 727-787-7250
13900 49TH STREET NORTH SE DECISION MADE: 19-JUL-05
CLEARWATER, FL 33762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIOM SIRESKOP SD
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K051602(TRADITIONAL)
ATTN: GARY JOHNSON PHONE NO : 610-448-1778
51 VALLEY STREAM PARKWAY E-50 SE DECISION MADE: 07-JUL-05
MALVERN, PA 19355-1406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEMIAL SPINAL IMPLANT
SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K051659(SPECIAL)
ATTN: TRACY L GRAY PHONE NO : 763-588-9873
4050 OLSON MEMORIAL HWY SE DECISION MADE: 13-JUL-05
SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55422
DEVICE: OSTEOVATION CMF BONE VOID FILLER
SKELETAL KINETICS, LLC 510(k) NO: K051784(SPECIAL)
ATTN: DURAN YETKINLER PHONE NO : 408-366-5002
10201 BUBB RD. SE DECISION MADE: 20-JUL-05
CUPERTINO, CA 95014-4167 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW CDS SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K051136(TRADITIONAL)
ATTN: DIANE E MINEAR PHONE NO : 978-749-1441
150 MINUTEMAN RD. SE DECISION MADE: 01-JUL-05
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT
SMITH & NEPHEW, INC. 510(k) NO: K051229(TRADITIONAL)
ATTN: JASON SELLS PHONE NO : 901-399-5520
1450 E. BROOKS RD. SE DECISION MADE: 20-JUL-05
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLC SCREW
SMITH & NEPHEW, INC. 510(k) NO: K051310(TRADITIONAL)
ATTN: BILL MCCALLUM PHONE NO : 508-261-3658
150 MINUTEMAN ROAD SE DECISION MADE: 26-JUL-05
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPP
SMITH & NEPHEW, INC. 510(k) NO: K051735(TRADITIONAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 E. BROOKS RD. SE DECISION MADE: 19-JUL-05
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MOD
SMITHS MEDICAL ASD, INC. 510(k) NO: K051524(TRADITIONAL)
ATTN: CYNTHIA ENGELHARDT PHONE NO : 603-352-3812
10 BOWMAN DRIVE SE DECISION MADE: 07-JUL-05
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLCO 4CIS GENERAL PLATE SYSTEM
SOLCO BIOMEDICAL CO., LTD. 510(k) NO: K051155(TRADITIONAL)
ATTN: SAEYOUNG AHN PHONE NO : 301-469-7912
7612 BARNUM ROAD SE DECISION MADE: 11-JUL-05
BETHESDA, MD 20817 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMNOMED MAS RXA
SOMNOMED LTD 510(k) NO: K050592(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
PO BOX 560 SE DECISION MADE: 12-JUL-05
STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS
STANDARD TEXTILE CO., INC. 510(k) NO: K041653(TRADITIONAL)
ATTN: BRADLEY J BUSHMAN PHONE NO : 513-761-9255
ONE KNOLLCREST DR. SE DECISION MADE: 01-JUL-05
P.O. BOX 371805 510(k) SUMMARY AVAILABLE FROM FDA
CINCINNATI, OH 45237-1600
DEVICE: EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001
STARGATE INTERNATIONAL, INC. 510(k) NO: K051631(TRADITIONAL)
ATTN: ROBERT H WALKER PHONE NO : 303-840-8206
10235 SOUTH PROGRESS WAY, #7 SE DECISION MADE: 27-JUL-05
PARKER, CO 80134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED COLD BIOPSY FORCEPS
STERILMED, INC. 510(k) NO: K042648(TRADITIONAL)
ATTN: BRUCE LESTER PHONE NO : 888-856-4870
11400 73RD AVE. NORTH, #100 SE DECISION MADE: 20-JUL-05
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED HOT BIOPSY FORCEPS
STERILMED, INC. 510(k) NO: K050136(TRADITIONAL)
ATTN: BRUCE R LESTER PHONE NO : 763-488-3400
11400 73RD AVE. NORTH, #100 SE DECISION MADE: 20-JUL-05
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRIN
STERYLAB S.R.L. 510(k) NO: K051506(TRADITIONAL)
ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW CT. SE DECISION MADE: 27-JUL-05
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPRUV A.I. CREAM WOUND AND SKIN EMULSION
STIEFEL LABORATORIES, INC. 510(k) NO: K041342(TRADITIONAL)
ATTN: MARY JANE CARR PHONE NO : 518-239-6901
ROUTE 145 SE DECISION MADE: 19-JUL-05
OAK HILL, NY 12460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIA 4.5 SPINAL SYSTEM
STRYKER SPINE 510(k) NO: K050461(TRADITIONAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 27-JUL-05
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE EDGE DETECTOR, MODEL 1118
SUN NUCLEAR CORP. 510(k) NO: K051921(TRADITIONAL)
ATTN: NOEL M DOWNEY PHONE NO : 321-259-6862
425-A PINEDA COURT SE DECISION MADE: 27-JUL-05
MELBOURNE, FL 32940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYMBIOS DISPOSABLE INFUSION PUMP KIT
SYMBIOS MEDICAL PRODUCTS, LLC 510(k) NO: K051474(SPECIAL)
ATTN: JEFFERY J ALHOLM PHONE NO : 317-331-8235
6131 WEST 80TH STREET SE DECISION MADE: 01-JUL-05
INDIANAPOLIS, IN 46278-1344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) LOW-PROFILE WRIST FIXATOR
SYNTHES (USA) 510(k) NO: K051049(TRADITIONAL)
ATTN: KATHY ANDERSON PHONE NO : 610-719-5860
1302 WRIGHTS LANE EAST SE DECISION MADE: 13-JUL-05
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM
SYNTHES (USA) 510(k) NO: K051600(TRADITIONAL)
ATTN: KATHY ANDERSON PHONE NO : 610-719-5860
1302 WRIGHTS LANE EAST SE DECISION MADE: 27-JUL-05
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
SYNTHES (USA) 510(k) NO: K051720(TRADITIONAL)
ATTN: KATHY ANDERSON PHONE NO : 610-719-5860
1302 WRIGHTS LANE EAST SE DECISION MADE: 25-JUL-05
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 E
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K050463(TRADITIONAL)
ATTN: SHU-MEI WU PHONE NO : 886 266 358080
4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 27-JUL-05
SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOX A/B QUICK CHEK
TECHLAB, INC. 510(k) NO: K050891(TRADITIONAL)
ATTN: DAVID M LYERLY PHONE NO : 540-953-1664
2001 KRAFT DR. SE DECISION MADE: 25-JUL-05
BLACKSBURG, VA 24060-6358 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
TECO DIAGNOSTICS 510(k) NO: K050823(TRADITIONAL)
ATTN: JIAN VAECHES PHONE NO : 714-693-7788
1268 NORTH LAKEVIEW AVE. SE DECISION MADE: 26-JUL-05
ANAHEIM, CA 92807 510(k) STATEMENT
DEVICE: BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT
THE BINDING SITE 510(k) NO: K042579(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 28-JUL-05
2425 WEST OLYMPIC BLVD. 510(k) SUMMARY AVAILABLE FROM FDA
SANTA MONICA, CA 90404
DEVICE: THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM
THERALASE INC. 510(k) NO: K050342(TRADITIONAL)
ATTN: ROGER WHITE PHONE NO : 905 947 8455
600 ALDEN ROAD SE DECISION MADE: 11-JUL-05
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
MARKHAM, ONTARIO, CANADA L3R 0E7
DEVICE: THERMAGE THERMACOOL COUPLING FLUID
THERMAGE, INC. 510(k) NO: K051710(TRADITIONAL)
ATTN: PAMELA M BUCKMAN PHONE NO : 510-259-7116
4058 POINT EDEN WAY SE DECISION MADE: 19-JUL-05
HAYWARD, CA 94545-3721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPI EASY TEMPORARY CAP
THOMMEN MEDICAL, AG 510(k) NO: K051527(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
11234 EL CAMINO REAL, STE. 200 SE DECISION MADE: 28-JUL-05
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORNIER ELBOW PROSTHESIS
TORNIER S.A. 510(k) NO: K050848(TRADITIONAL)
ATTN: MIREILLE LEMERY PHONE NO : 304 766 13898
161 RUE LAVOISIER SE DECISION MADE: 14-JUL-05
MONTBONNOT, SAINT-ISMIER, FRANCE 3510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QD KNEE/FOOT COIL, MODEL MJQJ-147A
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K051763(TRADITIONAL)
ATTN: MICHAELA MAHL PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 14-JUL-05
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K051833(TRADITIONAL)
ATTN: PAUL BIGGINGS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 15-JUL-05
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: 19-INCH (48CM) COLOR LCD MONITOR CDL1904A
TOTOKU ELECTRIC CO., LTD. 510(k) NO: K051403(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 812 683 45469
300 OYA, UEDA SE DECISION MADE: 14-JUL-05
NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30
TPC ADVANCED TECHNOLOGY, INC. 510(k) NO: K051547(SPECIAL)
ATTN: SCOTT BECKLEY PHONE NO : 626-810-4337
17588 E. ROWLAND ST. SE DECISION MADE: 14-JUL-05
CITY OF INDUSTRY, CA 91748 510(k) STATEMENT
DEVICE: OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES
TRIMED, INC. 510(k) NO: K050681(TRADITIONAL)
ATTN: KELLI ANDERSON PHONE NO : 661-312-7150
25864 TOURNAMENT RD. SUITE E SE DECISION MADE: 27-JUL-05
VALENCIA, CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALC-I-OSS
ULTRADENT PRODUCTS, INC. 510(k) NO: K042583(TRADITIONAL)
ATTN: TAMMY LAVERY PHONE NO : 801-553-4200
505 WEST 10200 SOUTH SE DECISION MADE: 19-JUL-05
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CO
UNITED CONTACT LENS, INC. 510(k) NO: K051184(TRADITIONAL)
ATTN: GAROLD L EDWARDS PHONE NO : 408-221-3860
2091 UPPER SCENIC DRIVE SE DECISION MADE: 01-JUL-05
FELTON, CA 95018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSEAR BONE CONDUCTION HEARING AID
UNITED HEARING SYSTEMS, INC. 510(k) NO: K050653(TRADITIONAL)
ATTN: RALPH CAMPAGNA PHONE NO : 860-564-4130
137 NORWICH RD. SE DECISION MADE: 01-JUL-05
CENTRAL VILLAGE, CT 06332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE
USGI MEDICAL 510(k) NO: K051919(SPECIAL)
ATTN: MARY LOU MOONEY PHONE NO : 949-369-3890
1140 CALLE CORDILLERA SE DECISION MADE: 26-JUL-05
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT
VALLEYLAB 510(k) NO: K051627(TRADITIONAL)
ATTN: HERBERT VINSON PHONE NO : 303-530-6469
5920 LONGBOW DR. SE DECISION MADE: 22-JUL-05
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K051180(TRADITIONAL)
ATTN: HEATHER CRAWFORD PHONE NO : 863-683-8680
5307 GREAT OAK DR. SE DECISION MADE: 22-JUL-05
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITESSE 2.0
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K051497(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-6990
3100 HANSEN WAY SE DECISION MADE: 18-JUL-05
PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
VASCULAR SOLUTIONS, INC. 510(k) NO: K051287(TRADITIONAL)
ATTN: LINDA BUSKLEIN PHONE NO : 763-656-4217
6464 SYCAMORE COURT NORTH SE DECISION MADE: 29-JUL-05
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMASK, MODELS 100, 200 AND 300
VITAL SIGNS COLORADO, INC. 510(k) NO: K051559(SPECIAL)
ATTN: TOM DIELMANN PHONE NO : 303-790-4835
11039 EAST LANSING CIR. SE DECISION MADE: 08-JUL-05
ENGLEWOOD, CO 80112 510(k) STATEMENT
DEVICE: GRANDIO
VOCO GMBH 510(k) NO: K051867(SPECIAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 27-JUL-05
BEND, OR 97702 510(k) STATEMENT
DEVICE: GRANDIO FLOW
VOCO GMBH 510(k) NO: K051868(SPECIAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 27-JUL-05
BEND, OR 97702 510(k) STATEMENT
DEVICE: MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
WALLAC OY 510(k) NO: K050960(SPECIAL)
ATTN: GUNNEL LAAKSONEN PHONE NO : 358 226 78111
MUSTIONKATU 6 SE DECISION MADE: 11-JUL-05
TURKU, FINLAND 20750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIROX
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K051249(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : +49 072 313705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 22-JUL-05
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GONGDONG DISPOSABLE VAGINAL SPECULUM
ZHEJIANG GONGDONG MEDICAL PLASTIC 510(k) NO: K050887(ABBREVIATED)
ATTN: WEIFENG ZHONG PHONE NO : 86 576 4051888
BEICHENG INDUSTRIAL AREA SE DECISION MADE: 11-JUL-05
HUANGYAN, CHINA 318020 510(k) STATEMENT
DEVICE: ELITE IMPLANT
ZHERMACK S.P.A. 510(k) NO: K050417(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 19-JUL-05
BEND, OR 97702 510(k) STATEMENT
DEVICE: HYDROGUM 5
ZHERMACK S.P.A. 510(k) NO: K051424(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 514-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 15-JUL-05
BEND, OR 97702 510(k) STATEMENT
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (WHITE, YELLOW)
ZIBO SINOCARE PLASTIC PRODUCTS CO.510(k) NO: K051723(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : +86 108 2387441
209 BEI SI HUAN ZHONG ROAD SE DECISION MADE: 15-JUL-05
HAIDIAN DISTRICT, BLDG. 1 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING, CHINA 100083
DEVICE: ANATOMICAL SHOULDER KEELED GLENOID
ZIMMER GMBH 510(k) NO: K051623(SPECIAL)
ATTN: BRANDON HIPSHER PHONE NO : 574-371-8083
P.O. BOX 708 SE DECISION MADE: 19-JUL-05
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 0
ZIMMER TRABECULAR 510(k) NO: K051756(SPECIAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 27-JUL-05
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES
ZIMMER, INC. 510(k) NO: K051098(TRADITIONAL)
ATTN: LAURA D WILLIAMS PHONE NO : 574-372-4523
P.O. BOX 708 SE DECISION MADE: 07-JUL-05
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRABECULAR METAL REVISION SHELL LINERS
ZIMMER, INC. 510(k) NO: K051516(SPECIAL)
ATTN: TONY KINGSLEY PHONE NO : 574-372-4485
P.O. BOX 708 SE DECISION MADE: 27-JUL-05
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZUTRON COLONOSCOPE STIFFENING DEVICE
ZUTRON MEDICAL 510(k) NO: K051068(TRADITIONAL)
ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320
543 LONG HILL AVENUE SE DECISION MADE: 11-JUL-05
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 260
TOTAL WITH SUMMARIES 221
TOTAL WITH STATEMENTS 39
Updated August 8, 2005
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