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Medical Devices
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January 2006 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-JAN-2006 THROUGH 31-JAN-2006
DEVICE: GLASS CERAMICS
3M ESPE AG DENTAL PRODUCTS 510(k) NO: K053438(TRADITIONAL)
ATTN: SABINE KRISCHER PHONE NO : 011 498 1527001238
ESPE PLATZ SE DECISION MADE: 18-JAN-06
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UROK ROCKING WHEELCHAIR, MODEL 700-4XX
A.M.G.MEDICAL, INC. 510(k) NO: K052548(TRADITIONAL)
ATTN: KENNETH LEVESQUE PHONE NO : 514 737 5251
8505 DALTON SE DECISION MADE: 06-JAN-06
MONTREAL, QUEBEC, CANADA H4T 1V5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 21
ABBOTT SPINE, INC. 510(k) NO: K052566(SPECIAL)
ATTN: NOAH BARTSCH PHONE NO : 512-533-1840
5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 06-JAN-06
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOQUANT PLUS
ADAC LABORATORIES 510(k) NO: K060020(TRADITIONAL)
ATTN: COLEEN A COLEMAN PHONE NO : 408-468-3051
540 ALDER DR. SE DECISION MADE: 20-JAN-06
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OPTILENE MESH LP
AESCULAP, INC. 510(k) NO: K053158(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-984-9072
3773 CORPORATE PKWY. SE DECISION MADE: 18-JAN-06
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSPEED UNI MOTOR SYSTEM
AESCULAP, INC. 510(k) NO: K053526(SPECIAL)
ATTN: KATHY A RACOSKY PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 18-JAN-06
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG
AFFINITY BIOLOGICALS INC. 510(k) NO: K052825(TRADITIONAL)
ATTN: DENISE FOULON PHONE NO : 905 304 9896
1395 SANDHILL DRIVE SE DECISION MADE: 20-JAN-06
ANCASTER, ONTARIO, CANADA L9G 4V5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREEZE
AFIKIM ELECTRIC VEHICLES 510(k) NO: K051028(TRADITIONAL)
ATTN: AVNER FISHBEIN PHONE NO : 011 972 46754814
SE DECISION MADE: 27-JAN-06
510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067
AGAMATRIX INC 510(k) NO: K052762(TRADITIONAL)
ATTN: CONNIE HERTEL PHONE NO : 617-252-6529
230 ALBANY STREET SE DECISION MADE: 23-JAN-06
CAMBRIDGE, MA 02139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION
AGFA CORPORATION 510(k) NO: K053634(SPECIAL)
ATTN: JEFFERY A JEDLICKA PHONE NO : 864-421-1815
10 SOUTH ACADEMY ST. SE DECISION MADE: 17-JAN-06
GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL
AKERS BIOSCIENCES, INC. 510(k) NO: K052697(TRADITIONAL)
ATTN: BARBARA A BAGBY PHONE NO : 856-848-8698
201 GROVE RD. SE DECISION MADE: 04-JAN-06
THOROFARE, NJ 08086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED EXTERNAL FIXATION DEVICES
ALLIANCE MEDICAL CORP. 510(k) NO: K052918(TRADITIONAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5300
10232 SOUTH 51ST ST. SE DECISION MADE: 27-JAN-06
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALOKA SD-3500 ULTRASOUND SYSTEM
ALOKA CO., LTD. 510(k) NO: K060059(TRADITIONAL)
ATTN: RICHARD J CEHOVSKY PHONE NO : 203-269-5088
10 FAIRFIELD BLVD. SE DECISION MADE: 13-JAN-06
WALLINGFORD, CT 06492-7502 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
AMERIWATER 510(k) NO: K051031(TRADITIONAL)
ATTN: BRIAN R BOWMAN PHONE NO : 937-461-8833
1257 STANLEY AVE. SE DECISION MADE: 06-JAN-06
DAYTON, OH 45404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECIMEN RETRIEVAL SYSTEM
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K060051(TRADITIONAL)
ATTN: CHERYL BLAKE PHONE NO : 949-713-8327
22872 AVENIDA EMPRESSA SE DECISION MADE: 19-JAN-06
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODULAR TROCAR SYSTEM
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K060096(TRADITIONAL)
ATTN: CHERYL BLAKE PHONE NO : 949-713-8327
22872 AVENIDA EMPRESSA SE DECISION MADE: 24-JAN-06
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS
ARTHREX, INC. 510(k) NO: K053338(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 26-JAN-06
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS
ARTHROCARE CORP. 510(k) NO: K053180(TRADITIONAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-735-6426
680 VAQUEROS AVE. SE DECISION MADE: 25-JAN-06
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPORTMESH
ARTIMPLANT AB 510(k) NO: K052830(TRADITIONAL)
ATTN: TERRY SHERIDAN POWELL PHONE NO : 201-476-0772
719 A STREET NE SE DECISION MADE: 19-JAN-06
WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES,
ASCEND EAGLE, INC. 510(k) NO: K052666(TRADITIONAL)
ATTN: JARILYN LIM PHONE NO : 707-648-1526
140-B DODD CT. SE DECISION MADE: 25-JAN-06
AMERICAN CANYON, CA 94503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B. BRAUN 0.2 MICRON FILTER
B. BRAUN MEDICAL, INC. 510(k) NO: K052773(TRADITIONAL)
ATTN: CHRISTINE FORD PHONE NO : 610-596-2367
901 MARCON BLVD. SE DECISION MADE: 24-JAN-06
ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERPICC
BARD ACCESS SYSTEMS, INC. 510(k) NO: K053501(SPECIAL)
ATTN: LYNN M KIRCHOFF PHONE NO : 801-595-0700
5425 WEST AMELIA EARNHART DR. SE DECISION MADE: 13-JAN-06
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO
BAUSCH & LOMB INCORPORATED 510(k) NO: K053124(TRADITIONAL)
ATTN: LISA GRANEY PHONE NO : 585-338-6612
1400 NORTH GOODMAN ST. SE DECISION MADE: 30-JAN-06
ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM
BIO-RAD LABORATORIES, INC. 510(k) NO: K060001(SPECIAL)
ATTN: JACKIE BUCKLEY PHONE NO : 510-741-5309
4000 ALFRED NOBEL DR. SE DECISION MADE: 20-JAN-06
HERCULES, CA 94547 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND
BIOKIT S.A. 510(k) NO: K060027(TRADITIONAL)
ATTN: JOAN GUIXER PHONE NO : 34 93 860
LLISSA D'AMUNT SE DECISION MADE: 26-JAN-06
BARCELONA, SPAIN 08186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEM
BIOLITEC, INC. 510(k) NO: K060050(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH ST., NW SE DECISION MADE: 23-JAN-06
WASHINGTON, DC 20004-5910 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MBCP
BIOMATLANTE 510(k) NO: K051774(TRADITIONAL)
ATTN: MYRIAM VINCENT PHONE NO : 332 280 20009
5, RUE EDOUARD BELIN SE DECISION MADE: 20-JAN-06
VIGNEUX DE BRETAGNE, FRANCE 44360 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MSAS-VANTAGE
BIOMERIDIAN, INT. 510(k) NO: K053004(SPECIAL)
ATTN: GENE SWIFT PHONE NO : 801-501-7517
12411 SOUTH 265 WEST, SUITE F SE DECISION MADE: 13-JAN-06
DRAPER, UT 84020-8671 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT
BIOMET MANUFACTURING, INC. 510(k) NO: K053299(TRADITIONAL)
ATTN: PATRICIA S BERES PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 05-JAN-06
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: OXICOM CONTROL
BIONOSTICS, INC. 510(k) NO: K053327(TRADITIONAL)
ATTN: KATHLEEN STORRO PHONE NO : 978-772-7070
7 JACKSON RD. SE DECISION MADE: 26-JAN-06
DEVENS, MA 01434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 9
BIOSITE INCORPORATED 510(k) NO: K052789(TRADITIONAL)
ATTN: RACHAEL S WILLIAMSON PHONE NO : 858-805-2719
9975 SUMMERS RIDGE ROAD SE DECISION MADE: 23-JAN-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIO ASPIRATION CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K051880(TRADITIONAL)
ATTN: CATHERINE A PETERS PHONE NO : 650-623-1755
2011 STIERLIN CT. SE DECISION MADE: 04-JAN-06
MOUNTAIN VIEW, CA 94043-4655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VE
BOSTON SCIENTIFIC CORP. 510(k) NO: K052964(TRADITIONAL)
ATTN: KATIE GERBENSKY PHONE NO : 763-494-1479
TWO SCIMED PLACE SE DECISION MADE: 06-JAN-06
MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIBERED IDC OCCLUSION SYSTEM
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K060078(SPECIAL)
ATTN: CHRISTINE M CAMERON PHONE NO : 508-683-4471
100 BOSTON SCIENTFIC WAY SE DECISION MADE: 31-JAN-06
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER
BRAUN GMBH 510(k) NO: K060006(SPECIAL)
ATTN: FRED SCHLADOR PHONE NO : 208-939-3447
P.O. BOX 1490 SE DECISION MADE: 31-JAN-06
EAGLE, ID 83616 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTER
BRYAN KEROPIAN DDS 510(k) NO: K053065(TRADITIONAL)
ATTN: BRYAN KEROPIAN PHONE NO : 818-881-7233
18607 VENTURA BLVD., SUITE 206 SE DECISION MADE: 03-JAN-06
TARZANA, CA 91356 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CDMX-H
CAMSIGHT CO., INC. 510(k) NO: K053221(TRADITIONAL)
ATTN: JAY CHOI PHONE NO : 323-259-1900
3380 SAN FERNANDO ROAD SE DECISION MADE: 12-JAN-06
LOS ANGELES, CA 90065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CG-7000DX-BT ECG RECORDER/TRANSMITTER
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K052556(SPECIAL)
ATTN: ALEX GONOROVSKY PHONE NO : 972 8 9484000
2 PEKERIS ST. SE DECISION MADE: 09-JAN-06
PO BOX 527 510(k) SUMMARY AVAILABLE FROM FDA
REHOVOT, ISRAEL 76100
DEVICE: TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221
CARDIAC ASSIST, INC. 510(k) NO: K052570(TRADITIONAL)
ATTN: TIM KRAUSKOPF PHONE NO : 412-963-7770
240 ALPHA DR. SE DECISION MADE: 17-JAN-06
PITTSBURGH, PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERHEART ECD
CARDIAC SCIENCE, INC. 510(k) NO: K052316(TRADITIONAL)
ATTN: KENNETH OLSON PHONE NO : 952-939-2912
5474 FELTL ROAD SE DECISION MADE: 03-JAN-06
EDINA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2
CARDIARC LTD. 510(k) NO: K053062(TRADITIONAL)
ATTN: JONATHAN KAHN PHONE NO : 202-637-5794
555 THIRTEENTH ST NW SE DECISION MADE: 06-JAN-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES
CARDINAL HEALTH 510(k) NO: K053272(SPECIAL)
ATTN: AMY HOYD PHONE NO : 847-578-2325
1500 WAUKEGAN RD. SE DECISION MADE: 05-JAN-06
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALARIS SAFETY MALE LUER
CARDINAL HEALTH, ALARIS PRODUCTS 510(k) NO: K053049(TRADITIONAL)
ATTN: STACY L LEWIS PHONE NO : 858-458-7830
10221 WATERIDGE CIRCLE SE DECISION MADE: 12-JAN-06
SAN DIEGO, CA 92121-2772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOSOFT PC ECG, USB VERSION
CARDIOSOFT, L.P. 510(k) NO: K052295(TRADITIONAL)
ATTN: S. MORADI PHONE NO : 713-623-4009
1776 YORKTOWN, SUITE LL-30 SE DECISION MADE: 13-JAN-06
HOUSTON, TX 77056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHROMOLITE SYSTEM
CHROMOGENEX PLC 510(k) NO: K053324(TRADITIONAL)
ATTN: CHRIS WILLIAMS PHONE NO : 440 155 4755444
UNITS 1&2 HEOL RHOSYN, SE DECISION MADE: 05-JAN-06
PARC DAFEN 510(k) SUMMARY AVAILABLE FROM FDA
LLANELLI, CARMARTHENSHIRE, UNITED THIRD PARTY REVIEW
DEVICE: RELI-ON ONE STEP, ORTHODONTIC ADHESIVE
CLASSONE ORTHODONTICS, INC. 510(k) NO: K053379(TRADITIONAL)
ATTN: JUDY RIBORDY PHONE NO : 806-799-0608
5064 50TH ST. SE DECISION MADE: 25-JAN-06
LUBBOCK, TX 79414 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINI-WRIGHT DIGITAL, MODEL 3120001
CLEMENT CLARKE INTL., LTD. 510(k) NO: K053156(TRADITIONAL)
ATTN: PHILIP HALLYBONE PHONE NO : 441 279 414969
EDINBURGH WAY SE DECISION MADE: 31-JAN-06
HARLOW, ESSEX, UNITED KINGDOM CM20510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DN
CLINICAL MICRO SENSORS 510(k) NO: K051435(TRADITIONAL)
ATTN: WILLIAM A COTY PHONE NO : 626-584-5900
757 SOUTH RAYMOND AVENUE SE DECISION MADE: 19-JAN-06
PASADENA, CA 91105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD
CODMAN & SHURTLEFF, INC. 510(k) NO: K053107(SPECIAL)
ATTN: SUSAN KAGAN PHONE NO : 508-880-8097
325 PARAMOUNT DR. SE DECISION MADE: 19-JAN-06
RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS
CODMAN & SHURTLEFF, INC. 510(k) NO: K053350(SPECIAL)
ATTN: BRIAN KANERVIKO PHONE NO : 508-828-3571
SE DECISION MADE: 19-JAN-06
510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSIMEND (TM) BONE GRAFT MATERIAL
COLLAGEN MATRIX, INC. 510(k) NO: K052812(TRADITIONAL)
ATTN: PEGGY C HANSEN PHONE NO : 201-405-1477
509 COMMERCE ST. SE DECISION MADE: 25-JAN-06
FRANKLIN LAKES,, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARAPOST PARACORE AUTOMIX 5ML
COLTENE/WHALEDENT AG 510(k) NO: K052820(TRADITIONAL)
ATTN: H. J. VOGELSTEIN PHONE NO : 212-289-4748
1349 LEXINGTON AVENUE SE DECISION MADE: 09-JAN-06
NEW YORK, NY 10128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRITIVIEW
CRITISENSE LTD. 510(k) NO: K051145(TRADITIONAL)
ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW CT. SE DECISION MADE: 18-JAN-06
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYT
CRYOCATH TECHNOLOGIES, INC. 510(k) NO: K053436(SPECIAL)
ATTN: FRED MILDER PHONE NO : 617-566-1915
204 CLINTON ROAD SE DECISION MADE: 13-JAN-06
BROOKLINE, MA 02445 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL ELEXUS (PC-1450) ELECTRIC WHEELCHAIR
DALTON MEDICAL CORP. 510(k) NO: K052534(TRADITIONAL)
ATTN: WILL RIDGWAY PHONE NO : 972-418-5129
1103 VENTURE CT. SE DECISION MADE: 27-JAN-06
CARROLLTON, TX 75006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K053445(TRADITIONAL)
ATTN: NATALIE S HECK PHONE NO : 574-372-7469
700 ORTHOPAEDIC DR. SE DECISION MADE: 06-JAN-06
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: DEPUY MODULAR M HEADS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K060031(SPECIAL)
ATTN: KELI K HANKEE PHONE NO : 574-372-7742
700 ORTHOPAEDIC DR. SE DECISION MADE: 31-JAN-06
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46580
DEVICE: DRG SLV TESTOSTERONE ELISA TEST
DRG INTL., INC. 510(k) NO: K052649(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 570-620-0198
150 CHERRY LANE RD. SE DECISION MADE: 27-JAN-06
EAST STROUDSBURG, PA 18301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK779
DUCKWORTH & KENT, LTD. 510(k) NO: K053176(TRADITIONAL)
ATTN: MARTIN LOCK PHONE NO : 011 441 462893254
7 MARQUIS BUSINESS CENTRE SE DECISION MADE: 30-JAN-06
ROYSTON RD. 510(k) STATEMENT
BALDOCK, HERTSFORDSHIRE, UNITED KINGDOM SG7 6XL
DEVICE: MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM
DURTECH SYSTEM CORP. 510(k) NO: K053285(TRADITIONAL)
ATTN: ADA LIN PHONE NO : 886 226 946022
3F, NO. 27, LANE 381 SE DECISION MADE: 05-JAN-06
FU-THE 1ST ROAD 510(k) STATEMENT
HIS-CHIH TAIPEI, CHINA (TAIWAN) 22THIRD PARTY REVIEW
DEVICE: KODAK CARESTREAM PACS
EASTMAN KODAK COMPANY 510(k) NO: K053347(SPECIAL)
ATTN: CAROLYN L WAGNER PHONE NO : 585-724-9488
343 STATE ST. SE DECISION MADE: 04-JAN-06
ROCHESTER, NY 14650 510(k) STATEMENT
DEVICE: BE PLUS / AURA-LTM64 AMPLIFIER
EB NEURO, S.P.A. 510(k) NO: K053606(SPECIAL)
ATTN: CARRI GRAHAM PHONE NO : 317-569-9500
11460 N. MERIDIAN ST. SE DECISION MADE: 24-JAN-06
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
CARMEL, IN 46032
DEVICE: EKOS MICRO-INFUSION SYSTEM
EKOS CORP. 510(k) NO: K053437(SPECIAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-482-1108
22030 20TH AVENUE S.E. SE DECISION MADE: 06-JAN-06
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98021
DEVICE: EMG HANDLE NEBULIZER NB02 SERIES
EMG TECHNOLOGY CO., LTD. 510(k) NO: K052438(ABBREVIATED)
ATTN: GENE R KULON PHONE NO : 570-510-3887
98 STANTON STREET SE DECISION MADE: 31-JAN-06
WILKES BARRE, PA 18702 510(k) STATEMENT
DEVICE: ENCOMPASS.NET
EMPIRIC SYSTEMS, LLC 510(k) NO: K053455(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 25-JAN-06
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDIUS ATAVI SYSTEM
ENDIUS, INC. 510(k) NO: K053267(TRADITIONAL)
ATTN: CHRISTINE KUNTZ-NASSIF PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 13-JAN-06
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESTECH COBRA ELECTROSURGICAL UNIT & CABLE
ENDOSCOPIC TECHNOLOGIES, INC. 510(k) NO: K053326(TRADITIONAL)
ATTN: CRAIG COOMBS PHONE NO : 510-337-0140
1193 SHERMAN STREET SE DECISION MADE: 06-JAN-06
ALAMEDA, CA 94501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MBATH 1000 (60")
ENNEKING MEDICAL INC. 510(k) NO: K052479(TRADITIONAL)
ATTN: STEPHEN WHITTENBURG PHONE NO : 816-300-4279
1801 GUINOTTE AVE. SE DECISION MADE: 26-JAN-06
KANSAS CITY, MO 64120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESKA-LIBUR HIP STEM
ESKA IMPLANTS GMBH & CO. 510(k) NO: K053557(SPECIAL)
ATTN: J. D WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 20-JAN-06
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESTECH CLEARVIEW MV ATRIAL DEPRESSOR
ESTECH, INC. 510(k) NO: K053021(TRADITIONAL)
ATTN: CRAIG COOMBS PHONE NO : 510-337-0140
1193 SHERMAN STREET SE DECISION MADE: 26-JAN-06
ALAMEDA, CA 94501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARMONIC SCALPEL BLADES AND SHEARS
ETHICON ENDO-SURGERY, INC. 510(k) NO: K053056(TRADITIONAL)
ATTN: ELIZABETH MILLER PHONE NO : 513-337-7146
4545 CREEK RD. SE DECISION MADE: 19-JAN-06
CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR TRANSTAR CURVED CUTTER STAPLER SET
ETHICON ENDO-SURGERY, INC. 510(k) NO: K053631(TRADITIONAL)
ATTN: WENDY TURNER PHONE NO : 513-337-8807
4545 CREEK RD. SE DECISION MADE: 30-JAN-06
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRACTION SYSTEM, DIGIT-TRAC 930
EVER PROSPEROUS INSTRUMENT, INC. 510(k) NO: K052453(TRADITIONAL)
ATTN: KE-MEN JEN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN STREET SE DECISION MADE: 13-JAN-06
HSIN CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESH, DENTAL IMPRESSION MATERIAL
EXACTA DENTAL PRODUCTS, INC. 510(k) NO: K053427(TRADITIONAL)
ATTN: RICHARD KEEN PHONE NO : 203-329-2700
1151 HOPE STREET SE DECISION MADE: 13-JAN-06
STAMFORD, CT 06907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUTURING WASHER
FIRST CALL, INC. 510(k) NO: K052642(TRADITIONAL)
ATTN: DINA L WEISSMAN PHONE NO : 203-287-0485
P.O. BOX 205 SE DECISION MADE: 17-JAN-06
DERBY, CT 06418 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MO
FOX HOLLOW TECHNOLOGIES 510(k) NO: K053460(SPECIAL)
ATTN: MELISSA MURPHY PHONE NO : 650-421-8579
740 BAY ROAD SE DECISION MADE: 13-JAN-06
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FD TENS 2030, MODEL DFJ24T
FUJI DYNAMICS LIMITED 510(k) NO: K052813(TRADITIONAL)
ATTN: ANTHONY AH YIN SHUN PHONE NO : +86 769 7728120
788 CHEUNG SHA WAN RD.UNIT 1-3 SE DECISION MADE: 25-JAN-06
23/F, LAWS COMMERCIAL PLAZA 510(k) SUMMARY AVAILABLE FROM FDA
KOWLOON, HONG KONG
DEVICE: GALIX ECG PROFESSIONAL STATION
GALIX BIOMEDICAL INSTRUMENTATION, 510(k) NO: K051163(TRADITIONAL)
ATTN: GREG VELEZ PHONE NO : 305-534-5905
2555 COLLINS AVE., C-5 SE DECISION MADE: 31-JAN-06
MIAMI BEACH, FL 33140 510(k) STATEMENT
DEVICE: DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SO
GE HEALTHCARE 510(k) NO: K051400(SPECIAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 20-JAN-06
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND
GE HEALTHCARE 510(k) NO: K052975(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 20-JAN-06
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES
GE HEALTHCARE 510(k) NO: K052976(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 13-JAN-06
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PF4 ENHANCED SOLID PHASE ELISA
GENETIC TESTING INSTITUTE 510(k) NO: K053559(SPECIAL)
ATTN: LEIGH ANN TIDEY PHONE NO : 262-754-1026
20925 CROSSROADS CIRCLE SE DECISION MADE: 20-JAN-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
WAUKESHA, WI 53186-4054
DEVICE: NITRILE BLUE POWDERED EXAMINATION GLOVES
GREAT GLOVE SDN BHD 510(k) NO: K052955(TRADITIONAL)
ATTN: LIM WEE-CHAI PHONE NO : 603 339 27880
LOT 5091, JALAN TERATAI , SE DECISION MADE: 19-JAN-06
BATU 5, OFF JALAN MERU 510(k) STATEMENT
KLANG, SELANGOR, MALAYSIA 41050
DEVICE: RAPHAEL COLOR
HAMILTON MEDICAL AG 510(k) NO: K052863(TRADITIONAL)
ATTN: CURDIN DANUSER PHONE NO : 41 81 6606010
VIA NOVA SE DECISION MADE: 06-JAN-06
RHAEZUENS, SWITZERLAND CH-7403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTPREP2 CENTRIFUGE SYSTEM
HARVEST TECHNOLOGIES, CORP. 510(k) NO: K052925(TRADITIONAL)
ATTN: JOHN D BONASERA PHONE NO : 508-732-7500
40 GRISSOM RD SE DECISION MADE: 04-JAN-06
PLYMOUTH, MA 02360 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)
HEIDELBERG ENGINEERING 510(k) NO: K052935(TRADITIONAL)
ATTN: GERHARD ZINSER PHONE NO : 49 622 164630
GERHART-HAUPTMANN-STRASSE 30 SE DECISION MADE: 13-JAN-06
DOSSENHEIM, GERMANY 69221 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SEVEN STAR NEEDLE
HELIO MEDICAL SUPPLIES, INC. 510(k) NO: K052723(TRADITIONAL)
ATTN: ERIC CHENG PHONE NO : 408-433-3355
606 CHARCOT AVE. SE DECISION MADE: 13-JAN-06
SAN JOSE, CA 95131 510(k) STATEMENT
DEVICE: OPTIGEN ALLERGEN SPECIFIC IGE ASSAY
HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K051677(TRADITIONAL)
ATTN: EMI ZYCHLINSKY PHONE NO : 650-961-5501
630 CLYDE CT. SE DECISION MADE: 23-JAN-06
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALTAIRE INTERVENTIONAL MR PACKAGE
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K053309(ABBREVIATED)
ATTN: DOUG THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 24-JAN-06
TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TREND 200 CPAP DEVICE, MODEL 5CP201; TRENDSET PC SOFTWARE, MODEL
HOFFRICHTER GMBH 510(k) NO: K053486(SPECIAL)
ATTN: STEPHEN H GORSKI PHONE NO : 262-594-2114
S65 W35739 PIPER RD. SE DECISION MADE: 04-JAN-06
EAGLE, WI 53119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLEX P SPEEDSET BONE CEMENT
HOWMEDICA OSTEONICS CORP 510(k) NO: K053198(TRADITIONAL)
ATTN: TIFFANI D ROGERS PHONE NO : 201-831-5612
325 CORPORATE DR. SE DECISION MADE: 26-JAN-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
HOWMEDICA OSTEONICS CORP 510(k) NO: K053472(SPECIAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
325 CORPORATE DR. SE DECISION MADE: 11-JAN-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-STAT CHEM8 + CARTRIDGE
I-STAT CORPORATION 510(k) NO: K053110(SPECIAL)
ATTN: PAUL VANDERWERF PHONE NO : 609-469-0242
104 WINDSOR CENTER DRIVE SE DECISION MADE: 13-JAN-06
EAST WINDSOR, NJ 08520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEGO, MODEL D1000
ICU MEDICAL, INC. 510(k) NO: K053106(SPECIAL)
ATTN: DALE FAIRCHILD PHONE NO : 949-366-4319
951 CALLE AMANECER SE DECISION MADE: 10-JAN-06
SAN CLEMENTE, CA 92673 510(k) STATEMENT
DEVICE: IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM
IKONISYS INC 510(k) NO: K052577(TRADITIONAL)
ATTN: S. MICHAEL SHARP PHONE NO : 203-776-0791
5 SCIENCE PARK SE DECISION MADE: 24-JAN-06
SUITE 1000 510(k) SUMMARY AVAILABLE FROM FDA
NEW HAVEN, CT 06511
DEVICE: ENDOPORE ANATOMIC ENDOSSEOUS DENTAL IMPLANT SYSTEM
INNOVA LIFE SCIENCES CORP. 510(k) NO: K052951(TRADITIONAL)
ATTN: HOWARD HOLSTEIN PHONE NO : 202-637-5813
555 13TH ST. N.W. SE DECISION MADE: 27-JAN-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PITT-EASY DENTAL IMPLANT SYSTEM
INNOVA LIFE SCIENCES CORP. 510(k) NO: K053242(SPECIAL)
ATTN: HOWARD HOLSTEIN PHONE NO : 202-637-5813
555 13TH ST. N.W. SE DECISION MADE: 06-JAN-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSIL PROS
INSTRUMENTATION LABORATORY CO. 510(k) NO: K053499(SPECIAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
526 RT. 303 SE DECISION MADE: 13-JAN-06
ORANGEBURG, NY 10962 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3160 MRI PATIENT MONITORING SYSTEM
INVIVO CORPORATION 510(k) NO: K053462(SPECIAL)
ATTN: NEIL BATTISTE PHONE NO : 800-331-3220
12601 RESEARCH PKWY. SE DECISION MADE: 18-JAN-06
ORLANDO, FL 32826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IBA PROTON THERAPY SYSTEM-PROTEUS 235
ION BEAM APPLICATIONS S.A. 510(k) NO: K053641(SPECIAL)
ATTN: JOHN B REISS PHONE NO : 215-972-7777
CENTRE SQUARE WEST, 38TH FLOOR SE DECISION MADE: 24-JAN-06
PHILADELPHIA, PA 19102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERAVIEW IC 5, MODEL XDP1
J. MORITA USA, INC. 510(k) NO: K053220(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-626-7715
1425 K ST. N.W. SE DECISION MADE: 06-JAN-06
SUITE 1100 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: KAPP BARI-RING, MODEL KS-BR-2005
KAPP SURGICAL INSTRUMENT, INC. 510(k) NO: K050384(TRADITIONAL)
ATTN: ALBERT SANTILLI PHONE NO : 216-587-4400
4919 WARRENSVILLE CENTER RD. SE DECISION MADE: 13-JAN-06
WARRENSVILLE HEIGHTS, OH 44128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K052680(TRADITIONAL)
ATTN: PAUL S LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 23-JAN-06
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR
KENDALL 510(k) NO: K053410(TRADITIONAL)
ATTN: JIM WELSH PHONE NO : 508-261-8532
15 HAMPSHIRE ST. SE DECISION MADE: 06-JAN-06
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOBY SURGICAL INTERNAL FIXATION SYSTEM
KOBY SURGICAL 510(k) NO: K060026(TRADITIONAL)
ATTN: PERRY FORRESTER PHONE NO : 281-398-5656
16350 PARK TEN PL., SUITE 101 SE DECISION MADE: 26-JAN-06
HOUSTON, TX 77084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
KODON(TIANJIN)ELECTRONIC&ELECTRICA510(k) NO: K051847(TRADITIONAL)
ATTN: LIU YI PHONE NO : +86 226 0526082
NO.31, CHANGJIANG ROAD, SE DECISION MADE: 05-JAN-06
NANKAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TIANJIN, CHINA 300193
DEVICE: STELLAR 404T
LARSEN & TOUBRO LIMITED 510(k) NO: K060058(TRADITIONAL)
ATTN: HARRY GUGNANI PHONE NO : 847-303-3906
1821 WALDEN OFFICE SQUARE SE DECISION MADE: 20-JAN-06
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
SCHAUMBURG, IL 60173 THIRD PARTY REVIEW
DEVICE: LEVITRONIX CENTRIMAG PRIMARY CONSOLE
LEVITRONIX LLC. 510(k) NO: K053630(SPECIAL)
ATTN: FARZAD PARSALE PHONE NO : 781-622-5075
45 FIRST AVE. SE DECISION MADE: 26-JAN-06
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026
LIFECORE BIOMEDICAL, INC. 510(k) NO: K053643(SPECIAL)
ATTN: BRIAN SMEKAL PHONE NO : 952-368-4300
3515 LYMAN BLVD. SE DECISION MADE: 23-JAN-06
CHASKA, MN 55318-3015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM
LIFESCAN, INC. 510(k) NO: K053529(SPECIAL)
ATTN: LISA MCGRATH PHONE NO : 408-263-9789
1000 GIBRALTAR DR. SE DECISION MADE: 17-JAN-06
MILPITAS, CA 95035-6312 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET
MAINE STANDARDS CO. 510(k) NO: K053247(TRADITIONAL)
ATTN: CHRISTINE BEACH PHONE NO : 207-892-1300
765 ROOSEVELT TRAIL SE DECISION MADE: 13-JAN-06
WINDHAM, ME 04062-5365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TESLAGUARD, MODEL EFT G04
MAMMENDORFER INSTITUTE FOR PHYSICS510(k) NO: K052119(TRADITIONAL)
ATTN: ROBERT N CLARK PHONE NO : 303-234-9412
13605 WEST 7TH AVE. SE DECISION MADE: 03-JAN-06
GOLDEN, CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCH
MEDICAL DEVICE TECHNOLOGIES, INC. 510(k) NO: K053518(SPECIAL)
ATTN: KRISTINE LIBERACKI PHONE NO : 800-338-0440
3600 SW 47TH AVE. SE DECISION MADE: 26-JAN-06
GAINESVILLE, FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATIN
MEDICAL ILLUMINATION INTERNATIONAL510(k) NO: K053227(TRADITIONAL)
ATTN: MIKE ALCALA PHONE NO : 818-838-3025
547 LIBRARY ST. SE DECISION MADE: 13-JAN-06
SAN FERNANDO, CA 91340 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NSK PRECISION APEX LOCATOR (PAL)
MEDICSENSE U.S.A. 510(k) NO: K053235(TRADITIONAL)
ATTN: GEORGE HATTUB PHONE NO : 508-479-6116
291 HILLSIDE AVENUE SE DECISION MADE: 24-JAN-06
SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM
MEDISON CO., LTD. 510(k) NO: K053530(TRADITIONAL)
ATTN: KYUNG-AM SHIM PHONE NO : 82 2 21941381
997-10 DAECHI-DONG SE DECISION MADE: 03-JAN-06
KANGNANM-KU 510(k) SUMMARY AVAILABLE FROM FDA
SEOUL, REPUBLIC OF KOREA 135-280 THIRD PARTY REVIEW
DEVICE: ACCUVIX V7 DIAGNOSTIC ULTRASOUND SYSTEM
MEDISON CO., LTD. 510(k) NO: K060087(TRADITIONAL)
ATTN: KYUNG-AM SHIM PHONE NO : 822 219 41381
997-10 DAECHI-DONG SE DECISION MADE: 24-JAN-06
GUANGNAM-G 510(k) SUMMARY AVAILABLE FROM FDA
SEOUL, REPUBLIC OF KOREA 135-280 THIRD PARTY REVIEW
DEVICE: MEDLINE PEDIATRIC WHEELCHAIRS
MEDLINE INDUSTRIES, INC. 510(k) NO: K053574(TRADITIONAL)
ATTN: LARA N SIMMONS PHONE NO : 847-578-6072
ONE MEDLINE PL. SE DECISION MADE: 25-JAN-06
MUNDELEIN, IL 60060 510(k) STATEMENT
DEVICE: PATHWAY - ATS/CHEPS
MEDOC LTD. ADVANCED MEDICAL SYSTEM510(k) NO: K052357(SPECIAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-479-6116
291 HILLSIDE AVENUE SE DECISION MADE: 19-JAN-06
SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFENET EXCHANGE SYSTEM
MEDTRONIC EMERGENCY RESPONSE SYSTE510(k) NO: K052854(TRADITIONAL)
ATTN: TERESA DAVIDSON PHONE NO : 425-867-4733
11811 WILLOWS RD., N.E. SE DECISION MADE: 20-JAN-06
REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLICI-T ANNULOPLASTY SYSTEM
MEDTRONIC HEART VALVES 510(k) NO: K052970(SPECIAL)
ATTN: PHIL NEURURER PHONE NO : 763-514-2875
8299 CENTRAL AVE., N.E. SE DECISION MADE: 11-JAN-06
SPRING LAKE PARK, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E
MEDTRONIC MINIMED 510(k) NO: K053177(TRADITIONAL)
ATTN: STACI ELLIS PHONE NO : 818-576-5959
18000 DEVONSHIRE STREET SE DECISION MADE: 31-JAN-06
NORTHRIDGE, CA 91325 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K053101(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 05-JAN-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K053474(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 06-JAN-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K053483(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 05-JAN-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6248VAL ADJUSTABLE VALVE
MEDTRONIC, INC. 510(k) NO: K052459(TRADITIONAL)
ATTN: MICHELLE NIVALA PHONE NO : 763-514-4459
7000 CENTRAL AVENUE NE SE DECISION MADE: 11-JAN-06
MS CW304 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55432-3576
DEVICE: PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
MEDWAVE, INC. 510(k) NO: K053185(TRADITIONAL)
ATTN: DONNA R LUNAK PHONE NO : 651-639-1227
4382 ROUND LAKE ROAD WEST SE DECISION MADE: 24-JAN-06
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXFEEL IMPLANT SYSTEM
MEGAGEN CO., LTD. 510(k) NO: K052369(TRADITIONAL)
ATTN: DAE KYU CHANG PHONE NO : 562-404-8466
13340 E. FIRESTONE BLVD. SE DECISION MADE: 10-JAN-06
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
SANTA FE SPRINGS, CA 90670
DEVICE: MERIT IMPRESS DIAGNOSTIC CATHETER
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K053171(TRADITIONAL)
ATTN: STEPHANIE ERSKINE PHONE NO : 801-208-4349
1600 WEST MERIT PKWY. SE DECISION MADE: 19-JAN-06
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ECHELON MICRO CATHETER
MICRO THERAPEUTICS, INC. 510(k) NO: K051990(TRADITIONAL)
ATTN: MARILYN R POURAZAR PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 04-JAN-06
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSULIS TISSUE ABLATION SYSTEM
MICROSULIS AMERICAS, INC. 510(k) NO: K052919(TRADITIONAL)
ATTN: TIMOTHY Y COWART PHONE NO : 678-467-9833
275 WYMAN STREET,SUITE 12 SE DECISION MADE: 13-JAN-06
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF
MIDI, INC. 510(k) NO: K052485(TRADITIONAL)
ATTN: WILLIAM STIMSON PHONE NO : 302-737-4297
125 SANDY DR. SE DECISION MADE: 17-JAN-06
NEWARK, DE 19713-1148 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIE - GAMMA CAMERA SYSTEMS
MIE AMERICA, INC. 510(k) NO: K053086(TRADITIONAL)
ATTN: KAY WARREN PHONE NO : 847-981-6100
420 BENNETT RD. SE DECISION MADE: 27-JAN-06
ELK GROVE VILLAGE, IL 60007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR
MINNTECH CORP. 510(k) NO: K050952(TRADITIONAL)
ATTN: LYNN LUEDERS PHONE NO : 763-553-2475
14605 28TH AVE. NORTH SE DECISION MADE: 31-JAN-06
MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM
MISONIX, INC. 510(k) NO: K042096(TRADITIONAL)
ATTN: RONALD R MANNA PHONE NO : 631-694-9555
1938 NEW HIGHWAY SE DECISION MADE: 26-JAN-06
FARMINGDALE, NY 11735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DBX STRIP
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K042829(TRADITIONAL)
ATTN: KAREN HARDWICK PHONE NO : 732-661-2354
125 MAY STREET SE DECISION MADE: 13-JAN-06
EDISON, NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "CATHY" STERILE DISPOSABLE I.V. CANNULA WITH CATHETER
MYCO MEDICAL SUPPLIES, INC. 510(k) NO: K042504(TRADITIONAL)
ATTN: SANJIV KUMAR PHONE NO : 919-678-0680
113 CENTRE WEST COURT SE DECISION MADE: 19-JAN-06
CARY, NC 27513 510(k) STATEMENT
DEVICE: OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR
NELLCOR PURITAN BENNETT, INC. 510(k) NO: K051271(TRADITIONAL)
ATTN: JAMES P GARVEY PHONE NO : 925-463-4479
4280 HACIENDA DR. SE DECISION MADE: 10-JAN-06
PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIGATOR ENDOSCOPY SYSTEM
NEOGUIDE SYSTEMS, INC. 510(k) NO: K052930(TRADITIONAL)
ATTN: MICHAEL A DANIEL PHONE NO : 925-254-5228
104 COOPER COURT SE DECISION MADE: 31-JAN-06
LOS GATOS, CA 95032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NT-1000
NEUROTHERM, INC. 510(k) NO: K052878(TRADITIONAL)
ATTN: WILLIAM RITTMAN PHONE NO : 978-777-3916
2 DEBUSH AVE. BUILDING A2 SE DECISION MADE: 23-JAN-06
MIDDLETON, MA 01949 510(k) STATEMENT
DEVICE: NEWPORT E360 VENTILATOR
NEWPORT MEDICAL INSTRUMENTS, INC. 510(k) NO: K053502(SPECIAL)
ATTN: RICHARD WATERS PHONE NO : 714-427-5811
1620 SUNFLOWER AVE. SE DECISION MADE: 10-JAN-06
COSTA MESA, CA 92626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXA COMPRESSION SCREW
NEXA ORTHOPEDICS, INC. 510(k) NO: K060071(TRADITIONAL)
ATTN: LOUISE M FOCHT PHONE NO : 858-866-0660
10675 SORRENTO VALLEY ROAD SE DECISION MADE: 26-JAN-06
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: NDR+/DIVA-D
NICAL SPA 510(k) NO: K053029(ABBREVIATED)
ATTN: GERALD SILVERMAN PHONE NO : 914-674-1085
71 ROSE STREET SE DECISION MADE: 06-JAN-06
HASTING ON HUDSON, NY 10706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCERA IMPLANT BRIDGE ZIRCONIA
NOBEL BIOCARE AB 510(k) NO: K053091(TRADITIONAL)
ATTN: PHUONG NGUYEN SON PHONE NO : 714-282-4800
22715 SAVI RANCH PARKWAY SE DECISION MADE: 27-JAN-06
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONYX II FINGER PULSE OXIMETER, MODEL 9550
NONIN MEDICAL, INC. 510(k) NO: K053130(TRADITIONAL)
ATTN: LORI M ROTH PHONE NO : 763-577-3093
13700 1ST AVE. NORTH SE DECISION MADE: 11-JAN-06
PLYMOUTH, MN 55441-5443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5
OPTO GLOBAL, INC 510(k) NO: K053044(TRADITIONAL)
ATTN: MARK T FUKUHARA PHONE NO : 916-771-4111
4021 DAGGETT DRIVE SE DECISION MADE: 24-JAN-06
GRANITE BAY, CA 95746 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GRAFTON DBM
OSTEOTECH, INC. 510(k) NO: K051188(TRADITIONAL)
ATTN: CHRISTOPHER TALBOT PHONE NO : 732-542-2800
51 JAMES WAY SE DECISION MADE: 03-JAN-06
EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSIGN
OXFORD BIOSIGNALS LIMITED 510(k) NO: K053112(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 13TH ST. NW SE DECISION MADE: 31-JAN-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANO
PAJUNK GMBH 510(k) NO: K053283(SPECIAL)
ATTN: CHRISTIAN QUAB PHONE NO : 049 770 49291533
KARL-HALL-STRASSE 1 SE DECISION MADE: 12-JAN-06
GEISINGEN, GERMANY D-78187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MUCOHARD
PARKELL, INC. 510(k) NO: K053516(TRADITIONAL)
ATTN: NELSON J GENDUSA PHONE NO : 631-249-1134
155 SCHMITT BLVD. SE DECISION MADE: 26-JAN-06
P.O. BOX 376 510(k) SUMMARY AVAILABLE FROM FDA
FARMINGDALE, NY 11735
DEVICE: PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K053522(SPECIAL)
ATTN: HERBERT VAN DYK PHONE NO : 49 703 14631734
HEWLETT-PACKARD STR.2 SE DECISION MADE: 10-JAN-06
BOEBLINGEN, BADEN-WTTBG, GERMANY D510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL E
PLANAR SYSTEMS, INC. 510(k) NO: K060136(TRADITIONAL)
ATTN: CRAIG HARSHMAN PHONE NO : 503-748-4661
1195 NW COMPTON DRIVE SE DECISION MADE: 31-JAN-06
BEAVERTON, OR 97006 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DISPOSABLE PVC EXAMINATION GLOVE, POWDERED AND POWDER-FREE
PRACTICAL PROTECTIVE PLASTIC MANUF510(k) NO: K053259(TRADITIONAL)
ATTN: GEORGE SU PHONE NO : 310-229-5748
1800 CENTURY PARK EAST SE DECISION MADE: 18-JAN-06
SUITE 600 510(k) SUMMARY AVAILABLE FROM FDA
CENTURY CITY, CA 90067 THIRD PARTY REVIEW
DEVICE: PRECISION BLENDER
PRECISION MEDICAL, INC. 510(k) NO: K053232(TRADITIONAL)
ATTN: JAMES PARKER PHONE NO : 610-262-6090
300 HELD DR. SE DECISION MADE: 10-JAN-06
NORTHAMPTON, PA 18067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VO
PRECISION OPTICS CORP. 510(k) NO: K053425(TRADITIONAL)
ATTN: ERWIN HEIDER PHONE NO : 978-630-1800
22 EAST BROADWAY SE DECISION MADE: 09-JAN-06
GARDNER, MA 01440-3338 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LIFESIGN DXPRESS, MODEL LSR2000
PRINCETON BIOMEDITECH CORP. 510(k) NO: K050955(TRADITIONAL)
ATTN: KYUNG-AH KIM PHONE NO : 732-274-1000
4242 U.S. RT. 1 SE DECISION MADE: 23-JAN-06
MONMOUTH JUNCTION, NJ 08852-1905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND M
PROTEIN POLYMER TECHNOLOGIES, INC.510(k) NO: K053548(TRADITIONAL)
ATTN: R. STEPHEN REITZLER PHONE NO : 858-558-6064
10655 SORRENTO VALLEY RD. SE DECISION MADE: 30-JAN-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER; PROTON PHC 109 EA
PROTON HEALTHCARE LTD. 510(k) NO: K051566(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 17-JAN-06
LITTLETON, CO 80127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FASTPACK TSH IMMUNOASSAY
QUALIGEN, INC. 510(k) NO: K052301(TRADITIONAL)
ATTN: DOROTHY PETERSON PHONE NO : 760-918-9165
2042 CORTE DEL NOGAL SE DECISION MADE: 04-JAN-06
CARLSBAD, CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA SYSTEM ETRNA GIOVINEZZA
QUANTA SYSTEM, S.P.A. 510(k) NO: K051113(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DRIVE SE DECISION MADE: 04-JAN-06
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLY
RADIANCY (ISRAEL) LTD. 510(k) NO: K052442(TRADITIONAL)
ATTN: MARGARET R FOURTE PHONE NO : 845-398-1647
40 RAMLAND ROAD SE DECISION MADE: 26-JAN-06
SUITE 10 510(k) SUMMARY AVAILABLE FROM FDA
ORANGEBURG, NY 10962
DEVICE: RANDOX CALIBRATION SERUM
RANDOX LABORATORIES, LTD. 510(k) NO: K053153(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 440 28 94422413
55 DIAMOND RD. SE DECISION MADE: 13-JAN-06
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02
RAYNER SURGICAL INC 510(k) NO: K052651(TRADITIONAL)
ATTN: MARK MULLANEY PHONE NO : 127 320 5401
SACKVILLE ROAD SE DECISION MADE: 19-JAN-06
HOVE, EAST SUSSEX, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIPAP FOCUS
RESPIRONICS (IRELAND) LIMITED 510(k) NO: K053168(TRADITIONAL)
ATTN: JOHN O'DEA PHONE NO : +35 391 709011
PARKMORE BUSINESS PARK, SE DECISION MADE: 04-JAN-06
PARKMORE WEST 510(k) SUMMARY AVAILABLE FROM FDA
GALWAY, IRELAND
DEVICE: LOFLO C5 CO2 SENSOR
RESPIRONICS NOVAMETRIX LLC 510(k) NO: K053174(SPECIAL)
ATTN: KEVIN MADER PHONE NO : 203-697-6466
5 TECHNOLOGY DRIVE SE DECISION MADE: 12-JAN-06
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS
ROEI MEDICAL TECHNOLOGIES, LTD. 510(k) NO: K053322(SPECIAL)
ATTN: JONATHAN S KAHN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 06-JAN-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSPLINT SPLINTING RIBBON
SATELEC 510(k) NO: K053328(TRADITIONAL)
ATTN: STEVEN SALESKY PHONE NO : 856-222-9988
130 GAITHER DRIVE SE DECISION MADE: 25-JAN-06
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
MT. LAUREL, NJ 08054
DEVICE: DELTA4
SCANDIDOS AB 510(k) NO: K052920(TRADITIONAL)
ATTN: THOMAS MATZEN PHONE NO : 46 18 602205
LEFFLERSGATAN 5 SE DECISION MADE: 12-JAN-06
UPPSALA, SWEDEN SE-754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAYFIELD SCANMATE MOBILE CT SYSTEM
SCHAERER MAYFIELD USA, INC. 510(k) NO: K053210(TRADITIONAL)
ATTN: JEFFREY K SHAPIRO PHONE NO : 202-637-5775
555 THIRTEENTH STREET, NW. SE DECISION MADE: 06-JAN-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS
SCIENT'X USA, INC. 510(k) NO: K053292(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 19-JAN-06
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENTINEL PANCREATIC AMYLASE
SENTINEL CH. SRL 510(k) NO: K051447(TRADITIONAL)
ATTN: DAVIDE SPADA PHONE NO : 39 02 3455141
5 VIA PRINCIPE EUGENIO SE DECISION MADE: 26-JAN-06
MILANO, ITALY 20155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
SHIJIAZHUANG BRILLIANT OCEAN PLAST510(k) NO: K052729(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
RM 1606 BLDG 1 JIANGXIANG YUAN SE DECISION MADE: 19-JAN-06
BEI SI HUAN ZHONG RD. 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING, CHINA 100083
DEVICE: MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION
SIEMENS MEDICAL SOLUTIONS, INC. 510(k) NO: K052423(TRADITIONAL)
ATTN: JUDITH CAMPBELL PHONE NO : 610-448-4918
51 VALLEY STREAM PARKWAY SE DECISION MADE: 13-JAN-06
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIROLASER
SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K053161(TRADITIONAL)
ATTN: FRITZ KOLLE PHONE NO : +49 625 1163294
FABRIKSTRASSE 31 SE DECISION MADE: 18-JAN-06
BENSHEIM, GERMANY D-64625 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KLOCKNER DENTAL IMPLANT, MODEL S3M
SOADCO, S.L. 510(k) NO: K052654(TRADITIONAL)
ATTN: MARIA MITJANETA PHONE NO : 376 800 590
AV FITER I ROSSELL SE DECISION MADE: 30-JAN-06
4 BIS LOCAL 2 510(k) SUMMARY AVAILABLE FROM FDA
ESCALDES-ENGORDANY, ANDORRA AD-700
DEVICE: DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS
SSL AMERICAS 510(k) NO: K052959(ABBREVIATED)
ATTN: CHRIS ROBINSON PHONE NO : 770-582-2152
3585 ENGINEERING DR. SE DECISION MADE: 27-JAN-06
NORCROSS, GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN
ST. JUDE MEDICAL 510(k) NO: K052575(TRADITIONAL)
ATTN: PATRICE STROMBERG PHONE NO : 952-933-4700
14901 DEVEAU PL. SE DECISION MADE: 19-JAN-06
MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRAUMANN COMPUTER AIDED RESTORATION SERVICE
STRAUMANN USA 510(k) NO: K052272(SPECIAL)
ATTN: ELAINE ALAN PHONE NO : 800-448-8168
60 MINUTETEMAN ROAD SE DECISION MADE: 03-JAN-06
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELL-CHEX AUTO
STRECK 510(k) NO: K053362(TRADITIONAL)
ATTN: KERRIE OETTER PHONE NO : 402-537-5215
7002 SOUTH 109TH ST. SE DECISION MADE: 13-JAN-06
OMAHA, NE 68128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER SCOPE WARMER
STRYKER ENDOSCOPY 510(k) NO: K053311(TRADITIONAL)
ATTN: CRYSTAL ONG PHONE NO : 408-754-2491
5900 OPTICAL CT. SE DECISION MADE: 27-JAN-06
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIATHLON TOTAL KNEE SYSTEM
STRYKER ORTHOPAEDICS 510(k) NO: K053514(TRADITIONAL)
ATTN: TIFFANI ROGERS PHONE NO : 201-831-5412
325 CORPORATE DRIVE SE DECISION MADE: 26-JAN-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHORT CITATION FEMORAL STEM
STRYKER ORTHOPAEDICS 510(k) NO: K053528(SPECIAL)
ATTN: TIFFANI ROGERS PHONE NO : 201-831-5412
325 CORPORATE DRIVE SE DECISION MADE: 13-JAN-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMEN
SUNTECH MEDICAL, INC. 510(k) NO: K053209(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SE DECISION MADE: 05-JAN-06
HASBROUCK HEIGHTS, NJ 07460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE
SURGICAL SPECIALTIES CORP. 510(k) NO: K053380(TRADITIONAL)
ATTN: ELIZABETH LAZARO PHONE NO : 610-404-1000
100 DENNIS DR. SE DECISION MADE: 18-JAN-06
READING, PA 19606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100
SWEMED LAB INTERNATIONAL AB 510(k) NO: K053208(ABBREVIATED)
ATTN: ANDERS JOHANSSON PHONE NO : 463 168 7777
BILLDALSVAGEN 2 SE DECISION MADE: 30-JAN-06
BILLDAL, SWEDEN SE-427 36 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPASYL POWER APPLICATOR
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K051933(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 W. COLLINS AVE. SE DECISION MADE: 03-JAN-06
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) CHRONOS-BETA-TCP
SYNTHES (USA) 510(k) NO: K053022(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-5868
1302 WRIGHTS LANE EAST SE DECISION MADE: 23-JAN-06
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
SYSMEX AMERICA, INC. 510(k) NO: K053135(TRADITIONAL)
ATTN: NINA GAMPERLING PHONE NO : 847-996-4675
ONE NELSON C. WHITE PARKWAY SE DECISION MADE: 04-JAN-06
MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE FINGER GUARD
T F & G PRODUCTS 510(k) NO: K052619(TRADITIONAL)
ATTN: MARIRUTH GURLEY PHONE NO : 530-679-0443
6956 ORO BANGOR HWY. SE DECISION MADE: 06-JAN-06
OROVILLE, CA 95966 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TECHDEVICE GUIDEWIRE
TECHDEVICE CORPORATION 510(k) NO: K053028(TRADITIONAL)
ATTN: LEIGH HAYWARD PHONE NO : 617-972-5808
650 PLEASANT ST. SE DECISION MADE: 31-JAN-06
WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED VINYL EXAMINATION GLOVE
TG MEDICAL (CHINA) INCORPORATION 510(k) NO: K052984(TRADITIONAL)
ATTN: WU KIN YEAP PHONE NO : 86 512 58422228
3 XITANG ROAD SE DECISION MADE: 11-JAN-06
XIZHANG TOWN 510(k) SUMMARY AVAILABLE FROM FDA
ZHANGJIAGANG, JIANGSU PROVINCE, CHINA 215614
DEVICE: POWDER FREE VINYL EXAMINATION GLOVE
TG MEDICAL (CHINA) INCORPORATION 510(k) NO: K052985(TRADITIONAL)
ATTN: WU KIN YEAP PHONE NO : 86 512 58422228
3 XITANG ROAD SE DECISION MADE: 19-JAN-06
XIZHANG TOWN 510(k) STATEMENT
ZHANGJIAGANG, JIANGSU PROVINCE, CHINA 215614
DEVICE: THERIGRAFT TCP PUTTY BONE VOID FILLER
THERICS, LLC 510(k) NO: K053228(TRADITIONAL)
ATTN: SUNIL SAINI PHONE NO : 609-514-7200
115 CAMPUS DR. SE DECISION MADE: 31-JAN-06
PRINCETON, NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AN
THUNDER TIGER CORP. 510(k) NO: K052822(TRADITIONAL)
ATTN: KE MIN JEN PHONE NO : 886 3 5208829
58 FU-CHIUN STREET SE DECISION MADE: 20-JAN-06
HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPER SHEATH INTRODUCER SHEATH
TOGO MEDIKIT CO., LTD. 510(k) NO: K052557(TRADITIONAL)
ATTN: HEIDI M ERICKSON PHONE NO : 763-694-3028
5905 NATHAN LANE SE DECISION MADE: 17-JAN-06
MAIL STOP P-25 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, MN 55442
DEVICE: EXCELART VANTAGE ZGV
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K060003(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DRIVE SE DECISION MADE: 18-JAN-06
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VERSATREK MYCO PZA KIT
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K052323(TRADITIONAL)
ATTN: NADINE M SULLIVAN PHONE NO : 608-837-3788
210 BUSINESS PARK DR. SE DECISION MADE: 19-JAN-06
SUN PRAIRIE, WI 53590 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K053243(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909
982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 20-JAN-06
CLEVELAND, OH 44131 510(k) STATEMENT
DEVICE: T-PIN
UNION SURGICAL LLC 510(k) NO: K053513(TRADITIONAL)
ATTN: AL WEISENBORN PHONE NO : 305-829-3437
834 CHESTNUT STREET SE DECISION MADE: 13-JAN-06
SUITE G114 510(k) SUMMARY AVAILABLE FROM FDA
PHILADELPHIA, PA 19107
DEVICE: VASCON NEUROPATH GUIDING CATHETER
VASCON LLC 510(k) NO: K052004(TRADITIONAL)
ATTN: ROBERTA D GOODE PHONE NO : 954-646-1215
4613 N. UNIVERSITY DRIVE SE DECISION MADE: 19-JAN-06
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
CORAL SPRINGS, FL 33067
DEVICE: IVENT 201
VERSAMED MEDICAL SYSTEMS, INC. 510(k) NO: K053270(SPECIAL)
ATTN: JERRY KORTEN PHONE NO : 845-770-2840
2 BLUE HILL PLAZA SE DECISION MADE: 27-JAN-06
BLDG. 2, 3RD FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
PEARL RIVER, NY 10965
DEVICE: PIONEER TC8080, COMPANION III
VIASYS NEURO CARE 510(k) NO: K053648(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 24-JAN-06
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL
VIDENT 510(k) NO: K052710(SPECIAL)
ATTN: BARBARA J LEWANDOWSKI PHONE NO : 714-961-6200
3150 EAST BIRCH ST. SE DECISION MADE: 13-JAN-06
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALIGNRT
VISION RT LIMITED 510(k) NO: K052682(TRADITIONAL)
ATTN: NORMAN SMITH PHONE NO : +44 208 9066620
DAWS HOUSE,33-35 DAWS LANE SE DECISION MADE: 06-JAN-06
LONDON, UNITED KINGDOM NW7 4SD 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSIO
W & H DENTALWERK BUERMOOS GMBH 510(k) NO: K052741(TRADITIONAL)
ATTN: GABRIELE WIENBECK PHONE NO : +43 627 46236397
IGNAZ GLASER STR. 53 SE DECISION MADE: 13-JAN-06
BUERMOOS, AUSTRIA A-5111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RM3 RENAL PRESERVATION SYSTEM
WATERS INSTRUMENTS, INC. 510(k) NO: K053169(SPECIAL)
ATTN: DAVE SCHOLLMAN PHONE NO : 800-426-9877
2112 15TH ST. N.W., SUITE A SE DECISION MADE: 17-JAN-06
ROCHESTER, MN 55901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFEMUR XTR HIP STEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K052915(SPECIAL)
ATTN: THERESA LEISTER PHONE NO : 901-867-4143
5677 AIRLINE RD. SE DECISION MADE: 27-JAN-06
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5TH METATARSAL FRACTURE SCREW
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K053136(TRADITIONAL)
ATTN: WESLEY L REED PHONE NO : 901-867-4701
5677 AIRLINE RD. SE DECISION MADE: 05-JAN-06
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFEMUR LX HIP STEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K053588(SPECIAL)
ATTN: THERESA LEISTER PHONE NO : 901-867-4143
5677 AIRLINE RD. SE DECISION MADE: 13-JAN-06
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOSET DBM PELLETS
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K053642(SPECIAL)
ATTN: THERESA LEISTER PHONE NO : 901-867-9971
5677 AIRLINE RD. SE DECISION MADE: 26-JAN-06
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER
XODUS MEDICAL, INC. 510(k) NO: K053321(TRADITIONAL)
ATTN: CRAIG KAFOREY PHONE NO : 724-337-5500
702 PROMINENCE DR. SE DECISION MADE: 19-JAN-06
NEW KENSINGTON, PA 15068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAUTERY TIP CLEANER, MODEL 30500
XODUS MEDICAL, INC. 510(k) NO: K053433(TRADITIONAL)
ATTN: BRENDA NIEL PHONE NO : 724-337-5500
702 PROMINENCE DR. SE DECISION MADE: 19-JAN-06
NEW KENSINGTON, PA 15068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOWHANDY ZAN100 USB
ZAN MESSGERATE GMBH 510(k) NO: K052176(TRADITIONAL)
ATTN: JIM LEWIS PHONE NO : 303-666-5555
908 MAIN STREET SE DECISION MADE: 12-JAN-06
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER DENTAL ONE-PIECE IMPLANT
ZIMMER DENTAL INC. 510(k) NO: K052997(TRADITIONAL)
ATTN: ERIN MCVEY PHONE NO : 760-929-4300
1900 ASTON AVE. SE DECISION MADE: 23-JAN-06
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANATOMICAL SHOULDER INVERSE/REVERSE
ZIMMER GMBH 510(k) NO: K053274(TRADITIONAL)
ATTN: DALENE T BINKLEY PHONE NO : 574-372-4907
P.O. BOX 708 SE DECISION MADE: 25-JAN-06
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED
ZIMMER, INC. 510(k) NO: K053226(TRADITIONAL)
ATTN: CINDY J DICKEY PHONE NO : 330-364-9493
200 WEST OHIO AVENUE SE DECISION MADE: 31-JAN-06
P.O. BOX 10 510(k) SUMMARY AVAILABLE FROM FDA
DOVER, OH 44622-0010
TOTAL 510(k)s THIS PERIOD 216
TOTAL WITH SUMMARIES 202
TOTAL WITH STATEMENTS 14
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