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510(k)s Final Decisions Rendered for December 2004 |
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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-DEC-2004 THROUGH 31-DEC-2004
DEVICE: A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS U
A & D ENGINEERING, INC. 510(k) NO: K042967(SPECIAL)
ATTN: JERRY WANG PHONE NO : 408-518-5113
1555 MCCANDLESS DR. SE DECISION MADE: 03-DEC-04
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET
AALTO SCIENTIFIC LTD. 510(k) NO: K042318(TRADITIONAL)
ATTN: ALAN J VEKICH PHONE NO : 760-431-7922
1959 KELLOGG AVE. SE DECISION MADE: 09-DEC-04
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEQUOS
AAP IMPLANTATE AG 510(k) NO: K033260(TRADITIONAL)
ATTN: MARC SEEGERS PHONE NO : 493 075 019192
LORENZWEG 5 SE DECISION MADE: 07-DEC-04
BERLIN, GERMANY 12099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAPTOMYCIN
AB BIODISK 510(k) NO: K042392(TRADITIONAL)
ATTN: ANNE BOLMSTROM PHONE NO : 46 8 7300760
DALVAGEN 10 SE DECISION MADE: 13-DEC-04
SOLNA, SWEDEN 16956 510(k) STATEMENT
DEVICE: MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U
ACRORAD CO., LTD. 510(k) NO: K043293(SPECIAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-570-0013
2305 GOLD MINE ROAD SE DECISION MADE: 17-DEC-04
BROOKEVILLE, MD 20833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508
ACUMEN MEDICAL, INC. 510(k) NO: K042381(TRADITIONAL)
ATTN: MARYBETH GAMBER PHONE NO : 650-352-5700
1400 TERRA BELLA BLVD. SE DECISION MADE: 28-DEC-04
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLLA CANNULATED INTERFERENCE SCREW
ADVANCED BIOMATERIALS 510(k) NO: K032830(TRADITIONAL)
ATTN: STEVE JANIN PHONE NO : 410-761-9411
504 MCCORMICK DRIVE SE DECISION MADE: 14-DEC-04
SUITE T 510(k) SUMMARY AVAILABLE FROM FDA
GLEN BURNIE, MD 21061
DEVICE: AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER
AESCULAP 510(k) NO: K040865(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 06-DEC-04
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BICONTACT HIP SYSTEM WITH U-CAP
AESCULAP 510(k) NO: K043079(SPECIAL)
ATTN: KATHY A RACOSKY PHONE NO : 800-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 08-DEC-04
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REUSABLE STERILCONTAINER FILTER MODEL #JK090
AESCULAP, INC. 510(k) NO: K041623(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 800-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 13-DEC-04
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)
AESCULAP, INC. 510(k) NO: K043041(SPECIAL)
ATTN: MATTHEW M HULL PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 09-DEC-04
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: PNEUTON VENTILATOR
AIRON CORPORATION 510(k) NO: K043085(SPECIAL)
ATTN: ERIC GJERDE PHONE NO : 321-821-9433
17 EAST MELBOURNE AVE. SE DECISION MADE: 20-DEC-04
MELBOURNE, FL 32901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLEY PCA MODULE, MODEL 8600
ALARIS MEDICAL SYSTEMS, INC. 510(k) NO: K043299(TRADITIONAL)
ATTN: STACY L LEWIS PHONE NO : 858-458-7830
10221 WATERIDGE CIR. SE DECISION MADE: 10-DEC-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALL FLOW PULMONARY FUNCTION FILTER
ALLIANCE TECH MEDICAL, INC. 510(k) NO: K043148(TRADITIONAL)
ATTN: KEITH LOWREY PHONE NO : 541-476-1628
611 SOUTH SCHOOLHOUSE CREEK RD SE DECISION MADE: 13-DEC-04
GRANTS PASS, OR 97526 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXFLEX TOTAL HIP SYSTEM
ALPHATEC/NEXMED 510(k) NO: K042252(SPECIAL)
ATTN: ELLEN A YARNALL PHONE NO : 760-431-9286
6110 CORTE DEL CEDRO SE DECISION MADE: 06-DEC-04
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II
AMEDITECH, INC. 510(k) NO: K042975(TRADITIONAL)
ATTN: JOHN WU PHONE NO : 858-535-1968
10340 CAMINO SANTA FE, SUITE F SE DECISION MADE: 29-DEC-04
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: DREAM CLEANSE "S" SCALER, DREAM COMPACT "S" SCALER
AMERICAN GREEN DENT. MFG, INC. 510(k) NO: K033044(TRADITIONAL)
ATTN: ANDREW ROWE PHONE NO : 323-265-7000
3432 E. 14TH STREET SE DECISION MADE: 21-DEC-04
LOS ANGELES, CA 90023 510(k) STATEMENT
DEVICE: INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K042592(TRADITIONAL)
ATTN: KRISTYN BENSON PHONE NO : 952-930-6027
10700 BREN RD., WEST SE DECISION MADE: 14-DEC-04
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANIMAS MODEL IR1250 INSULIN INFUSION PUMP
ANIMAS CORP. 510(k) NO: K042873(TRADITIONAL)
ATTN: THOMAS L PARKER PHONE NO : 484-568-1257
200 LAWRENCE DR. SE DECISION MADE: 10-DEC-04
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (
ANSELL HEALTHCARE PRODUCTS, INC. 510(k) NO: K042817(TRADITIONAL)
ATTN: LON D MCLLVAIN PHONE NO : 334-615-2562
1635 INDUSTRIAL ROAD SE DECISION MADE: 06-DEC-04
DOTHAN, AL 36303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES
ANTHOGYR 510(k) NO: K040671(TRADITIONAL)
ATTN: ERIC GENEVE PHONE NO : 33 4 50580237
164 RUE DE TROIS LACS SE DECISION MADE: 14-DEC-04
SALLANCHES, FRANCE 74700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX K2 HIP SYSTEM
APEX SURGICAL, LLC. 510(k) NO: K041950(TRADITIONAL)
ATTN: EDWARD J CHEAL, PH.D PHONE NO : 508-947-6500
12 HARDING STREET,SUITE 202 SE DECISION MADE: 21-DEC-04
LAKEVILLE, MA 02347 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MISTAR, MODEL V3.2
APOLLO MEDICAL IMAGING TECHNOLOGY 510(k) NO: K043350(TRADITIONAL)
ATTN: QING YANG PHONE NO : 03 985 99316
26 HOOD STREET NORTH SE DECISION MADE: 15-DEC-04
NORTH BALWYN 510(k) SUMMARY AVAILABLE FROM FDA
MELBOURNE, VIC, AUSTRALIA 3104 THIRD PARTY REVIEW
DEVICE: ACS MODEL NCP-2
APPLIED CARDIAC SYSTEMS 510(k) NO: K042413(TRADITIONAL)
ATTN: R. BEN GHADIMI PHONE NO : 949-855-9366
22912 EL PACIFICO DR. SE DECISION MADE: 09-DEC-04
LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20
APPLIED MEDICAL TECHNOLOGY, INC. 510(k) NO: K043027(SPECIAL)
ATTN: DEREK WILLIAMS PHONE NO : 216-475-5577
15653 NEO PKWY. SE DECISION MADE: 02-DEC-04
CLEVELAND, OH 44128 510(k) STATEMENT
DEVICE: PATHFINDER
ARMSTRONG HEALTHCARE LIMITED 510(k) NO: K041477(TRADITIONAL)
ATTN: PATRICK A FINLAY PHONE NO : 44 162 8536900
KNAVES BEECH BUSINESS CENTRE SE DECISION MADE: 09-DEC-04
LOUDWATER 510(k) SUMMARY AVAILABLE FROM FDA
HIGH WYCOMBE, UNITED KINGDOM HP10 9QR
DEVICE: ARTHREX SUTURE GRAFTING KIT
ARTHREX, INC. 510(k) NO: K041553(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 10-DEC-04
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR
ARTHREX, INC. 510(k) NO: K043337(SPECIAL)
ATTN: SALLY FOUST PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 14-DEC-04
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003
ARTHROCARE CORP. 510(k) NO: K042947(TRADITIONAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-735-6426
680 VAQUEROS AVE. SE DECISION MADE: 27-DEC-04
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER
ASTRA TECH, INC. 510(k) NO: K043241(SPECIAL)
ATTN: BRUCE MANNING PHONE NO : 508-393-3100
20 MAIN STREET SE DECISION MADE: 23-DEC-04
NORTHBOROUGH, MA 01532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPRESS AND OASIS CHEST DRAIN
ATRIUM MEDICAL CORP. 510(k) NO: K043140(SPECIAL)
ATTN: JOSEPH P DE PAOLO PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 08-DEC-04
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: RADIANCE PORCELAIN
AURIDENT, INC. 510(k) NO: K042638(TRADITIONAL)
ATTN: BRUCE D SPIVACK PHONE NO : 714-523-5544
610 S. STATE COLLEGE BLVD. SE DECISION MADE: 17-DEC-04
FULLERTON, CA 92831 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM
BARCO NV BARCOVIEW 510(k) NO: K042221(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE SE DECISION MADE: 30-DEC-04
# 931 510(k) SUMMARY AVAILABLE FROM FDA
ALBUQUERQUE, NM 87111
DEVICE: ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM
BAYER HEALTHCARE, LLC 510(k) NO: K043158(TRADITIONAL)
ATTN: GEORGE M TANCOS PHONE NO : 574-262-6928
1884 MILES AVE. SE DECISION MADE: 22-DEC-04
P.O. BOX 70 510(k) SUMMARY AVAILABLE FROM FDA
ELKHART, IN 46515-2004
DEVICE: ASCENSIA ELITE DIABETES CARE SYSTEM
BAYER HEALTHCARE, LLC 510(k) NO: K043311(SPECIAL)
ATTN: GEORGE M TANCOS PHONE NO : 574-262-6928
1884 MILES AVE. SE DECISION MADE: 22-DEC-04
P.O. BOX 70 510(k) SUMMARY AVAILABLE FROM FDA
ELKHART, IN 46514-0070
DEVICE: MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE
BECTON DICKINSON & CO. 510(k) NO: K043397(SPECIAL)
ATTN: PASQUALE AMATO PHONE NO : 201-847-4513
1 BECTON DRIVE SE DECISION MADE: 29-DEC-04
FRANKLIN LAKES, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD ONECATH
BECTON DICKINSON INFUSION THERAPY 510(k) NO: K042862(TRADITIONAL)
ATTN: LESLIE WOOD PHONE NO : 801-565-2504
9450 SOUTH STATE ST. SE DECISION MADE: 03-DEC-04
SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM
BECTON, DICKINSON & CO. 510(k) NO: K042932(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 02-DEC-04
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPLUS
BERKELEY ADVANCED BIOMATERIALS, IN510(k) NO: K042636(SPECIAL)
ATTN: FRANCOIS GENIN PHONE NO : 510-883-0500
1933 DAVIS ST. SUITE 307 SE DECISION MADE: 14-DEC-04
SAN LEANDRO, CA 94577 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER
BEST MEDICAL INTERNATIONAL, INC. 510(k) NO: K043117(TRADITIONAL)
ATTN: JOSEPH C WANG PHONE NO : 800-336-4970
7643 FULLERTON RD. SE DECISION MADE: 09-DEC-04
SPRINGFIELD, VA 22153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTI
BIO-RAD LABORATORIES, INC. 510(k) NO: K041658(TRADITIONAL)
ATTN: CHRISTOPHER BENSTEN PHONE NO : 425-498-1709
6565 185TH AVE., N.E. SE DECISION MADE: 20-DEC-04
REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL
BIO-RAD LABORATORIES, INC. 510(k) NO: K043108(TRADITIONAL)
ATTN: SUZANNE S PARSONS PHONE NO : 949-598-1467
9500 JERONIMO RD. SE DECISION MADE: 07-DEC-04
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOCARE SYSTEMS PREMIR 818
BIOCARE SYSTEMS, INC. 510(k) NO: K042532(TRADITIONAL)
ATTN: CLAY ANSELMO PHONE NO : 303-223-4303
518 17TH STREET SE DECISION MADE: 13-DEC-04
SUITE 1350 510(k) SUMMARY AVAILABLE FROM FDA
DENVER, CO 80202
DEVICE: BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116
BIOCHECK, INC. 510(k) NO: K041619(TRADITIONAL)
ATTN: ROBIN J HELLEN, M.S. PHONE NO :
9418 LASAINE AVE. SE DECISION MADE: 17-DEC-04
NORTHRIDGE, CA 91325 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HELICOBACTER PYLORI IGG ELISA
BIOHIT PLC 510(k) NO: K041238(TRADITIONAL)
ATTN: ROBERT P GEARTY PHONE NO : 800 922 0784
3535 ROUTE 66 SE DECISION MADE: 13-DEC-04
BUILDING 4 510(k) SUMMARY AVAILABLE FROM FDA
NEPTUNE, NJ 07753
DEVICE: VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN
BIOMERIEUX, INC. 510(k) NO: K042946(TRADITIONAL)
ATTN: JOLYN TENLLADO PHONE NO : 314-731-8386
595 ANGLUM RD. SE DECISION MADE: 07-DEC-04
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM
BIOMERIEUX, INC. 510(k) NO: K042963(TRADITIONAL)
ATTN: JOLYN TENLLADO PHONE NO : 314-731-8386
595 ANGLUM RD. SE DECISION MADE: 13-DEC-04
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM
BIOMERIEUX, INC. 510(k) NO: K043230(TRADITIONAL)
ATTN: JOLYN TENLLADO PHONE NO : 314-731-8386
595 ANGLUM RD. SE DECISION MADE: 30-DEC-04
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN
BIOMERIEUX, INC. 510(k) NO: K043237(TRADITIONAL)
ATTN: JOLYN TENLLADO PHONE NO : 314-731-8386
595 ANGLUM RD. SE DECISION MADE: 23-DEC-04
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDALLION MODULAR HIP SYSTEM
BIOMET MANUFACTURING, INC. 510(k) NO: K041850(TRADITIONAL)
ATTN: LONNIE WITHAM PHONE NO : 574-372-1510
P.O. BOX 587 SE DECISION MADE: 21-DEC-04
WARSAW, IN 46581-0578 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODULAR ARTHRODESIS NAIL
BIOMET, INC. 510(k) NO: K042409(TRADITIONAL)
ATTN: GARY BAKER PHONE NO : 574-267-6639
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 02-DEC-04
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-CORE INTERFERENCE SCREW
BIOMET, INC. 510(k) NO: K042552(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-371-1152
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 14-DEC-04
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M2A/C2A ACETABULAR SYSTEM
BIOMET, INC. 510(k) NO: K042841(TRADITIONAL)
ATTN: PATRICIA S ANDBORN BERES PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 21-DEC-04
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46582
DEVICE: MIMIX MP BONE VOID FILLER
BIOMET, INC. 510(k) NO: K043280(SPECIAL)
ATTN: KACY ARNOLD PHONE NO : 574-267-6639
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 21-DEC-04
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANEMIAPRO SELF-SCREENER
BIOSAFE LABORATORIES, INC. 510(k) NO: K042379(TRADITIONAL)
ATTN: JACK A MAGGIORE PHONE NO : 773-693-0400
100 FIELD DRIVE #240 SE DECISION MADE: 15-DEC-04
LAKE FOREST, IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300
BIOSITE INCORPORATED 510(k) NO: K042723(TRADITIONAL)
ATTN: JERRREY R DAHLEN PHONE NO : 858-455-4808
11030 ROSELLE ST. SE DECISION MADE: 07-DEC-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET
BIOTEQUE CORP. 510(k) NO: K033210(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 30-DEC-04
FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML
BIOTOP TECHNOLOGY CO., LTD. 510(k) NO: K043038(SPECIAL)
ATTN: MARK LIEN PHONE NO : 886 2 23957606
12 F-2, NO. 130 SE DECISION MADE: 22-DEC-04
CHUNG-HSIAO E.ROAD,SEC.2 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN) 100
DEVICE: OUTPATIENT III MINOR SURGERY LIGHT
BURTON MEDICAL PRODUCTS CORP. 510(k) NO: K042395(TRADITIONAL)
ATTN: ASLE ASMUL PHONE NO : 818-701-8700
21100 LASSEN ST. SE DECISION MADE: 01-DEC-04
CHATSWORTH, CA 91311 510(k) STATEMENT
DEVICE: ACUPUNCTURE NEEDLES
C.A.I. INDUSTRIES CORP. 510(k) NO: K041652(TRADITIONAL)
ATTN: LU RAO PHONE NO : 626-448-6622
10166 RUSH ST. SE DECISION MADE: 29-DEC-04
SOUTH EL MONTE, CA 91007 510(k) STATEMENT
DEVICE: BARD INLAYOPTIMA URETERAL STENT WITH SUTURE
C.R. BARD, INC. 510(k) NO: K043193(SPECIAL)
ATTN: FRANCES E HARRISON PHONE NO : 770-784-6257
8195 INDUSTRIAL BLVD SE DECISION MADE: 07-DEC-04
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUID STABLE HBA1C CONTROL
CANTERBURY SCIENTIFIC LTD. 510(k) NO: K043070(TRADITIONAL)
ATTN: MAURICE OWEN PHONE NO : 643 343 3345
14 POPE STREET SE DECISION MADE: 09-DEC-04
CHRISTCHURCH, CANTERBURY, NEW ZEAL510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PMP4 OXY PRO
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K043162(TRADITIONAL)
ATTN: BORIS ARADOVSKY PHONE NO : 972 894 84000
2 PEKERIS ST. SE DECISION MADE: 29-DEC-04
PO BOX 527 510(k) SUMMARY AVAILABLE FROM FDA
REHOVOT, ISRAEL 76100
DEVICE: ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAININ
CARDINAL HEALTH 510(k) NO: K042574(TRADITIONAL)
ATTN: ERICA SETHI PHONE NO : 847-785-3337
1500 WAUKEGAN RD. SE DECISION MADE: 08-DEC-04
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BIOZDX HEMODYNAMIC MONITOR
CARDIODYNAMICS INTERNATIONAL CORP.510(k) NO: K041294(TRADITIONAL)
ATTN: DENNIS HEPP PHONE NO : 858-535-0202
6175 NANCY RIDGE DR., #300 SE DECISION MADE: 08-DEC-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERASYS - ZR
CERASYS, INC. 510(k) NO: K042548(TRADITIONAL)
ATTN: JIN KIM PHONE NO : 562-942-9700
11761 TELEGRAPH ROAD SE DECISION MADE: 03-DEC-04
SANTA FE SPRINGS, CA 90670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
CHURCHILL MEDICAL SYSTEMS, INC. 510(k) NO: K041038(ABBREVIATED)
ATTN: KEITH PALUCH PHONE NO : 603-743-5988
87 VENTURE DR. SE DECISION MADE: 21-DEC-04
ENTERPRISE PARK 510(k) SUMMARY AVAILABLE FROM FDA
DOVER, NH 03820
DEVICE: DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE
COLLAGEN MATRIX, INC. 510(k) NO: K040888(TRADITIONAL)
ATTN: PEGGY HANSEN PHONE NO : 201-405-1477
509 COMMERCE ST. SE DECISION MADE: 01-DEC-04
FRANKLIN LAKES,, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093
CONFLUENT SURGICAL,INC 510(k) NO: K042588(TRADITIONAL)
ATTN: ERIC ANKERUD PHONE NO : 781-693-2333
101A FIRST AVE. SE DECISION MADE: 09-DEC-04
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER
CONSOLIDATED MACHINE CORP. 510(k) NO: K041833(ABBREVIATED)
ATTN: ARTHUR TRAPOTSIS PHONE NO : 617-783-2607
76 ASHFORD ST. SE DECISION MADE: 10-DEC-04
BOSTON, MA 02134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: ZILVER 635 BILIARY STENT
COOK, INC. 510(k) NO: K043481(SPECIAL)
ATTN: LELAND KEYT PHONE NO : 800-346-2686
750 DANIELS WAY PO BX 489 SE DECISION MADE: 29-DEC-04
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM
COPAN DIAGNOSTICS, INC. 510(k) NO: K042970(TRADITIONAL)
ATTN: CYNTHIA SINCLAIR PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 07-DEC-04
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE
CORDIS CORP. 510(k) NO: K040592(TRADITIONAL)
ATTN: DAVID KORNHAUSER PHONE NO : 786-313-8704
14201 N.W. 60TH AVE. SE DECISION MADE: 17-DEC-04
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COSMEDENT PIT & FISSURE SEALANT
COSMEDENT, INC. 510(k) NO: K042823(TRADITIONAL)
ATTN: JAMES L SANDRIK PHONE NO : 312-644-9586
401 NORTH MICHIGAN AVE. SE DECISION MADE: 01-DEC-04
SUITE 2500 510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60611
DEVICE: CLINICAL ELECTRONIC THERMOMETER
COTRONIC MANUFACTURING 510(k) NO: K032434(TRADITIONAL)
ATTN: SHINE WAN PHONE NO : 86 755 27477681
JIU WEI, XI XIANG SE DECISION MADE: 27-DEC-04
BAO AN ZONE 510(k) SUMMARY AVAILABLE FROM FDA
SHEN ZHEN, CHINA
DEVICE: DOC BAND-POSTOP
CRANIAL TECHNOLOGIES, INC. 510(k) NO: K042385(TRADITIONAL)
ATTN: TIMOTHY R LITTLEFIELD PHONE NO : 480-505-1840
1395 WEST AUTO DR. SE DECISION MADE: 17-DEC-04
TEMPE, AZ 85284 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WHEELCHAIR, MODEL 8500-II
CYCLING AND HEALTH TECH. INDUSTRY 510(k) NO: K043332(TRADITIONAL)
ATTN: ZEN-JYE CHEN PHONE NO : 886 4 22842291
111-X60, LANE 68 SE DECISION MADE: 13-DEC-04
FU-HSING N. RD. 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN) 407
DEVICE: CONTROL PLASMA N, PROC CONTROL PLASMA
DADE BEHRING, INC. 510(k) NO: K042333(TRADITIONAL)
ATTN: RADAMES RIESGO PHONE NO : 305-480-7558
500 GBC DR. SE DECISION MADE: 01-DEC-04
NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENZYGNOST F+2 (MONOCLONAL) TEST KIT
DADE BEHRING, INC. 510(k) NO: K042687(TRADITIONAL)
ATTN: DONNA WOLF PHONE NO : 302-631-0384
P.O. BOX 6101 SE DECISION MADE: 10-DEC-04
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS
DADE BEHRING, INC. 510(k) NO: K042941(TRADITIONAL)
ATTN: RADAMES RIESGO PHONE NO : 305-480-7558
GLASCO B500 M.S. 514 SE DECISION MADE: 02-DEC-04
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N
DATEX-OHMEDA 510(k) NO: K043276(TRADITIONAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM RD. SE DECISION MADE: 23-DEC-04
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TUF LINK SILICONE RELINER
DENTATUS USA, LTD. 510(k) NO: K042931(TRADITIONAL)
ATTN: THOMAS MURPHY PHONE NO : 212-481-1010
192 LEXINGTON AVE. SE DECISION MADE: 08-DEC-04
NEW YORK, NY 10016 510(k) STATEMENT
DEVICE: DUCERA ALLCERAM
DENTSPLY INTL. 510(k) NO: K043247(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 WEST PHILADELPHIA STREET SE DECISION MADE: 22-DEC-04
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: BLUE ORTHOCORD SUTURE
DEPUY MITEK 510(k) NO: K043298(SPECIAL)
ATTN: RUTH C FORSTADT PHONE NO : 781-251-3188
249 VANDERBILT DR. SE DECISION MADE: 10-DEC-04
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY C-STEM AMT HIP PROSTHESIS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K042959(SPECIAL)
ATTN: DINA L WEISSMAN PHONE NO : 574-371-4905
700 ORTHOPAEDIC DR. SE DECISION MADE: 22-DEC-04
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: LPS UPPER EXTREMITY
DEPUY, INC. 510(k) NO: K042664(TRADITIONAL)
ATTN: TIFFANI D ROGERS PHONE NO : 574-371-4927
P.O. BOX 988 SE DECISION MADE: 08-DEC-04
700 ORTHOPAEDIC DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: SALICYLATE-SL ASSAY
DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K042329(TRADITIONAL)
ATTN: NANCY OLSCAMP PHONE NO : 800 565 0265
16 MCCARVILLE ST. SE DECISION MADE: 27-DEC-04
WEST ROYALTY INDUSTRIAL PARK 510(k) STATEMENT
CHARLOTTETOWN, PRINCE EDWARD, CANADA C1E 2A6
DEVICE: MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-
DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K042362(TRADITIONAL)
ATTN: NANCY OLSCAMP PHONE NO : 902 566 1396
16 MCCARVILLE ST. SE DECISION MADE: 27-DEC-04
CHARLOTTETOWN, CANADA C1E 2A6 510(k) STATEMENT
DEVICE: EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS
DIOMED, INC. 510(k) NO: K041957(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 01-DEC-04
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO D-TRONPLUS
DISETRONIC MEDICAL SYSTEMS AG 510(k) NO: K043000(SPECIAL)
ATTN: SCOTT THIEL PHONE NO : 317-521-3362
9115 HAGUE ROAD SE DECISION MADE: 01-DEC-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRAGON HEART PISTON SYRINGE
DRAGON HEART MEDICAL DEVICES CO., 510(k) NO: K042547(ABBREVIATED)
ATTN: JINA YU PHONE NO : 630-833-6998
188 INDUSTRIAL DRIVE SE DECISION MADE: 01-DEC-04
SUITE 108 510(k) STATEMENT
ELMHURST, IL 60126
DEVICE: DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR K
DREW SCIENTIFIC LTD. 510(k) NO: K043378(ABBREVIATED)
ATTN: DIANE HILL PHONE NO : 441 229 432089
SOWERBY WOODS BUSINESS PARK SE DECISION MADE: 29-DEC-04
PARK ROAD 510(k) STATEMENT
BARROW IN FURNESS CUMBRIA, UNITED KINGDOM LA14 4QR
DEVICE: CAPSULE TENSION RING INSERTER, MODEL 7-810
DUCKWORTH & KENT, LTD. 510(k) NO: K042478(TRADITIONAL)
ATTN: MARTIN LOCK PHONE NO : 441 462 893254
TERENCE HOUSE, 7 MARQUIS SE DECISION MADE: 28-DEC-04
BUSINESS CENTRE ROYSTON RD. 510(k) STATEMENT
BALDOCK, HERTS, UNITED KINGDOM SG7 6XL
DEVICE: PANALIGHT-BLU, MODEL 4175
DUSA PHARMACEUTICALS, INC. 510(k) NO: K043164(TRADITIONAL)
ATTN: SCOTT LUNDAHL PHONE NO : 978-657-7500
25 UPTON DR. SE DECISION MADE: 10-DEC-04
WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATIO
EBI, L.P. 510(k) NO: K042772(TRADITIONAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 13-DEC-04
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESTENT NT35 BILIARY STENT SYSTEM
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K042985(SPECIAL)
ATTN: KEVIN DRISKO PHONE NO : 949-250-2416
ONE EDWARDS WAY SE DECISION MADE: 23-DEC-04
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONIT
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K043103(SPECIAL)
ATTN: PAULA A TORRIANNI PHONE NO : 714-250-2418
ONE EDWARDS WAY SE DECISION MADE: 09-DEC-04
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO LYSUS INFUSION SYSTEM
EKOS CORP. 510(k) NO: K043269(SPECIAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-482-1108
22030 20TH AVENUE S.E. SE DECISION MADE: 22-DEC-04
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98021
DEVICE: DIFOTI USB 2.0 SYSTEM
ELECTRO-OPTICAL SCIENCES, INC. 510(k) NO: K043068(TRADITIONAL)
ATTN: MICHAEL GREENEBAUM PHONE NO : 914-591-3783
1 BRIDGE ST. SUITE 15 SE DECISION MADE: 29-DEC-04
IRVINGTON-ON HUDSON, NY 10533 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXI-STAT SP02 EAR SENSOR
ELEKON INDUSTRIES U.S.A., INC. 510(k) NO: K042675(TRADITIONAL)
ATTN: KRISTA OAKES PHONE NO : 972-849-5167
2300 MCDERMOTT RD. SE DECISION MADE: 06-DEC-04
#200-207 510(k) SUMMARY AVAILABLE FROM FDA
PLANO, TX 75025
DEVICE: DISPOSABLE NON-ADHESIVE SPO2 SENSORS
ELEKON INDUSTRIES U.S.A., INC. 510(k) NO: K042705(TRADITIONAL)
ATTN: KRISTA OAKES PHONE NO : 972-849-5167
2300 MCDERMOTT RD. SE DECISION MADE: 29-DEC-04
#200-207 510(k) SUMMARY AVAILABLE FROM FDA
PLANO, TX 75025
DEVICE: EMG MODEL SUA01 SUCTION UNIT
EMG TECHNOLOGY CO., LTD. 510(k) NO: K042349(ABBREVIATED)
ATTN: LEONARD FRIER PHONE NO : 410-354-3300
914 WEST PATAPSCO AVE. SE DECISION MADE: 16-DEC-04
BALTIMORE, MD 21230 510(k) STATEMENT
DEVICE: INFINITY ELECTROTHERAPY SYSTEM
EMPI 510(k) NO: K042057(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 17-DEC-04
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE3
ETHICON ENDO-SURGERY, INC. 510(k) NO: K042777(TRADITIONAL)
ATTN: KIMBERLY SHOEMAKER PHONE NO : 513-337-8123
4545 CREEK RD. SE DECISION MADE: 01-DEC-04
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYNECARE PROLENE FASTENER SYSTEM
ETHICON, INC. 510(k) NO: K042603(TRADITIONAL)
ATTN: SEAN O'BRYAN PHONE NO : 908-218-2456
ROUTE 22 WEST SE DECISION MADE: 22-DEC-04
SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMUS STENT AND DELIVERY SYSTEM
EV3 INC 510(k) NO: K043243(SPECIAL)
ATTN: GLEN D SMYTHE PHONE NO : 763-398-7391
4600 NATHAN LN. NORTH SE DECISION MADE: 09-DEC-04
PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEMEX SYSTEM GENTA FAST BONE CEMENT
EXACTECH, INC. 510(k) NO: K043403(SPECIAL)
ATTN: LISA SIMPSON PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 28-DEC-04
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FEMSPEC DISPOSABLE VAGINAL SPECULUM
FEMSPEC L.L.C. 510(k) NO: K041757(TRADITIONAL)
ATTN: GERALD JAY SANDERS PHONE NO : 415-561-2565
220 HALLECK STREET, SUITE 120 SE DECISION MADE: 23-DEC-04
P.O. BOX 29450 510(k) SUMMARY AVAILABLE FROM FDA
SAN FRANCISCO, CA 94129-0450
DEVICE: FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K043244(SPECIAL)
ATTN: ARTHUR EILINSFELD PHONE NO : 781-402-9068
95 HAYDEN AVE. SE DECISION MADE: 20-DEC-04
LEXINGTON, MA 02420-9192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT CA 15-3 ASSAY
FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K042732(TRADITIONAL)
ATTN: KIMBERLY PETERSON PHONE NO : 610-240-3828
201 GREAT VALLEY PKWY. SE DECISION MADE: 22-DEC-04
MALVERN, PA 19355-1307 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES
GE MEDICAL SYST. INFORMATION TECHN510(k) NO: K042148(TRADITIONAL)
ATTN: LISA M BAUMHARDT PHONE NO : 262-293-1699
8200 WEST TOWER AVE. SE DECISION MADE: 03-DEC-04
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINIA LIGHTSPEED
GE MEDICAL SYSTEMS F.I. HAIFA 510(k) NO: K043381(TRADITIONAL)
ATTN: LAURENCE BIGIO PHONE NO : 972 4 8563633
4 HAYOZMA ST. SE DECISION MADE: 23-DEC-04
TIRAT HACARMEL, ISRAEL 30200 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GE OEC FLUOROSTAR
GE OEC MEDICAL SYSTEMS, INC. 510(k) NO: K043076(TRADITIONAL)
ATTN: JEFF WAGNER PHONE NO : 801-536-4668
384 WRIGHT BROTHERS DR. SE DECISION MADE: 22-DEC-04
SALT LAKE CITY, UT 84116 510(k) STATEMENT
DEVICE: GENCHEM ISE ELECTROLYTE REFERENCE
GENCHEM, INC. 510(k) NO: K040971(TRADITIONAL)
ATTN: C.C. ALLAIN PHONE NO : 714-529-7125
471 W. LAMBERT RD., SUITE 107 SE DECISION MADE: 22-DEC-04
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALCIUM, AZO DYE REAGENT
GENCHEM, INC. 510(k) NO: K040972(TRADITIONAL)
ATTN: C.C. ALLAIN PHONE NO : 714-529-7125
471 W. LAMBERT RD., SUITE 107 SE DECISION MADE: 27-DEC-04
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BUN REAGENT
GENCHEM, INC. 510(k) NO: K040973(TRADITIONAL)
ATTN: C.C. ALLAIN PHONE NO : 714-529-7125
471 W. LAMBERT RD., SUITE 107 SE DECISION MADE: 27-DEC-04
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOSE OXIDASE, GLUCOSE
GENCHEM, INC. 510(k) NO: K040974(TRADITIONAL)
ATTN: C.C. ALLAIN PHONE NO : 714-529-7125
471 W. LAMBERT RD., SUITE 107 SE DECISION MADE: 27-DEC-04
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENCHEM CO2 ACID REAGENT
GENCHEM, INC. 510(k) NO: K040975(TRADITIONAL)
ATTN: C.C. ALLAIN PHONE NO : 714-529-7125
471 W. LAMBERT RD., SUITE 107 SE DECISION MADE: 27-DEC-04
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENCHEM CREATININE REAGENT
GENCHEM, INC. 510(k) NO: K040976(TRADITIONAL)
ATTN: C.C. ALLAIN PHONE NO : 714-529-7125
471 W. LAMBERT RD., SUITE 107 SE DECISION MADE: 27-DEC-04
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENCHEM ELECTROLYTE BUFFER
GENCHEM, INC. 510(k) NO: K040977(TRADITIONAL)
ATTN: C.C. ALLAIN PHONE NO : 714-529-7125
471 W. LAMBERT RD., SUITE 107 SE DECISION MADE: 27-DEC-04
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
GENEMED, INC. 510(k) NO: K042427(SPECIAL)
ATTN: DAVID BALZER PHONE NO : 203-263-5951
660 MAIN STREET SOUTH SE DECISION MADE: 03-DEC-04
SUITE 7 510(k) STATEMENT
WOODBURY, CT 06798
DEVICE: GERBER DOUBLE ELECTRIC BREAST PUMP
GERBER PRODUCTS CO. 510(k) NO: K043098(TRADITIONAL)
ATTN: RANGA RANGANATHAN PHONE NO : 231-928-2831
445 STATE ST. SE DECISION MADE: 15-DEC-04
FREMONT, MI 49413 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: STERICHEK BLOOD LEAK REAGENT STRIPS
HACH COMPANY 510(k) NO: K042322(TRADITIONAL)
ATTN: DAVID A MORRIS, PH.D. PHONE NO : 219-262-2060
23575 COUNTY ROAD 106 SE DECISION MADE: 07-DEC-04
ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORRECT DENTAL IMPRESSION MATERIAL
HANDAE CHEMICAL CO., LTD. 510(k) NO: K042860(TRADITIONAL)
ATTN: JAE HO YU PHONE NO : 824 353 42191
560-24, SONGDU-RI, JINCHEON-UP SE DECISION MADE: 03-DEC-04
JINCHEON-GUN,CHUNGCHEONGBUK-DO, RE510(k) STATEMENT365-802
DEVICE: WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER),
HANGZHOU HUA'AN MEDICAL & HEALTH I510(k) NO: K041693(TRADITIONAL)
ATTN: JI BO PHONE NO : 86 571 88734065
BUILDING 2, BAIMIAO INDU. PARK SE DECISION MADE: 02-DEC-04
ECONOMIC DEVELOP. ZONE WUCHANG 510(k) STATEMENT
HANGZHOU, ZHEJIANG, CHINA 310023
DEVICE: H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM
HEALTH & LIFE CO., LTD. 510(k) NO: K043186(SPECIAL)
ATTN: PAUL HUNG PHONE NO : 886 2 82271300
9F, NO.186, JIAN YI ROAD SE DECISION MADE: 06-DEC-04
CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT
DEVICE: OSTIM
HERAEUS KULZER, INC. 510(k) NO: K030052(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 219-299-6662
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 06-DEC-04
SOUTH BEND, IN 46614-2517 510(k) STATEMENT
DEVICE: FLEXITIME XTREME
HERAEUS KULZER, INC. 510(k) NO: K042878(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6662
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 17-DEC-04
SOUTH BEND, IN 46614-2517 510(k) STATEMENT
DEVICE: HEALTHSTAR ELITE
HILL LABORATORIES CO. 510(k) NO: K043239(TRADITIONAL)
ATTN: HOWARD A HILL PHONE NO : 610-644-2867
3 BACTON HILL RD. SE DECISION MADE: 22-DEC-04
P.O. BOX 2028 510(k) SUMMARY AVAILABLE FROM FDA
FRAZER, PA 19355 THIRD PARTY REVIEW
DEVICE: HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PC
HOSPIRA, INC. 510(k) NO: K043256(SPECIAL)
ATTN: PATRICIA MELERSKI PHONE NO : 224-212-4880
275 N. FIELD DR., BLDG. H-2 SE DECISION MADE: 06-DEC-04
D-389 510(k) SUMMARY AVAILABLE FROM FDA
LAKE FOREST, IL 60045-5045
DEVICE: HOVEROUND SE-3 POWERCHAIR
HOVEROUND CORP. 510(k) NO: K042920(TRADITIONAL)
ATTN: TONY DIGIOVANNI PHONE NO : 941-739-6200
2151 WHITFIELD INDUSTRIAL WAY SE DECISION MADE: 03-DEC-04
SARASOTA, FL 34243 510(k) STATEMENT
DEVICE: HOVEROUND E100 POWER CHAIR
HOVEROUND CORP. 510(k) NO: K043069(TRADITIONAL)
ATTN: TONY DIGIOVANNI PHONE NO : 941-739-6200
2151 WHITFIELD INDUSTRIAL WAY SE DECISION MADE: 03-DEC-04
SARASOTA, FL 34243 510(k) STATEMENT
DEVICE: MODIFICATION TO T2 PROXIMAL HUMERAL NAIL
HOWMEDICA OSTEONICS CORP. 510(k) NO: K043404(SPECIAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
325 CORPORATE DRIVE SE DECISION MADE: 27-DEC-04
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGPLAN AND PANPLAN
IMAGING SCIENCES INTL., INC. 510(k) NO: K041078(TRADITIONAL)
ATTN: EDWARD J MARANDOLA PHONE NO : 215-997-5666
1910 NORTH PENN RD. SE DECISION MADE: 23-DEC-04
HATFIELD, PA 19440 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAMMA-B 1,25-DIHYDROXY VITAMIN D
IMMUNODIAGNOSTIC SYSTEMS LTD. 510(k) NO: K042519(ABBREVIATED)
ATTN: PAUL PUNTIN PHONE NO : 440 191 5190660
10 DIDCOT WAY, SE DECISION MADE: 01-DEC-04
BOLDEN BUSINESS PARK 510(k) STATEMENT
BOLDON, TYNE & WEAR, UNITED KINGDOM NE35 9PD
DEVICE: MODIFICATION TO: VIEWSTATION
IMPAC MEDICAL SYSTEMS, INC. 510(k) NO: K043412(SPECIAL)
ATTN: THOMAS H FARIS PHONE NO : 650-623-8807
100 WEST EVELYN AVE. SE DECISION MADE: 20-DEC-04
MOUNTAIN VIEW, CA 94041-1464 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRABECULAR METAL KNEE SYSTEM AUGMENTS
IMPLEX CORP. 510(k) NO: K040487(TRADITIONAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 21-DEC-04
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 12-LEAD GLOVE
INEEDMD 510(k) NO: K033559(TRADITIONAL)
ATTN: IRVING WIESEN, ESQ. PHONE NO : 203-327-1372
860 CANAL STREET SE DECISION MADE: 22-DEC-04
STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IR VIEWER
INFRARED IMAGING SYSTEMS, INC. 510(k) NO: K042679(TRADITIONAL)
ATTN: DALE SIEGEL PHONE NO : 614-675-3729
1275 KINNEAR ROAD SE DECISION MADE: 10-DEC-04
COLUMBUS, OH 43212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
INNOVA LIFE SCIENCES CORP. 510(k) NO: K043190(SPECIAL)
ATTN: HOWARD HOLSTEIN PHONE NO : 202-637-5813
555 13TH ST. N.W. SE DECISION MADE: 14-DEC-04
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EAR THERMOMETER, MODEL WL-320X
INNOVATECH, INC 510(k) NO: K042631(TRADITIONAL)
ATTN: TONY C CHANG PHONE NO : 886 422 972787
NO 5, ALLEY 5, SE DECISION MADE: 22-DEC-04
LANE CHENG HSING, CHUNG CHING 510(k) STATEMENT
PEI TUN DIST. TAICHUNG, CHINA (TAIWAN)
DEVICE: COATEST SP FVIII
INSTRUMENTATION LABORATORY CO. 510(k) NO: K042576(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 02-DEC-04
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTEX MYOGLOBIN
INSTRUMENTATION LABORATORY CO. 510(k) NO: K042982(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 22-DEC-04
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSIL RECOMBIPLASTIN
INSTRUMENTATION LABORATORY CO. 510(k) NO: K043184(SPECIAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 22-DEC-04
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K042825(TRADITIONAL)
ATTN: DARLENE M WALSH PHONE NO : 609-275-0050
311 ENTERPRISE DR. SE DECISION MADE: 21-DEC-04
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITANIUM MESH IMPLANT
INTERPORE CROSS INTL. 510(k) NO: K041407(TRADITIONAL)
ATTN: WENDY SPIELBERGER PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 29-DEC-04
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ALTIUS OCT SYSTEM
INTERPORE CROSS INTL. 510(k) NO: K043229(SPECIAL)
ATTN: WENDY SPIELBERGER PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 21-DEC-04
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTR
INTUITIVE SURGICAL, INC. 510(k) NO: K043153(SPECIAL)
ATTN: MICHAEL H YRAMATEGUI PHONE NO : 408-523-2100
950 KIFER RD. SE DECISION MADE: 15-DEC-04
SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WATCH PAT 100S
ITAMAR MEDICAL LTD. 510(k) NO: K042916(TRADITIONAL)
ATTN: JONATHAN S KAHN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 29-DEC-04
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSTEMP.C&B PLUS
IVOCLAR VIVADENT, INC. 510(k) NO: K042820(TRADITIONAL)
ATTN: DONNA HARTNETT PHONE NO : 716-691-2260
175 PINEVIEW DR. SE DECISION MADE: 14-DEC-04
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: SYSTEMP.LINK
IVOCLAR VIVADENT, INC. 510(k) NO: K042846(TRADITIONAL)
ATTN: DONNA M HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 20-DEC-04
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: SYSTEMP.CEM
IVOCLAR VIVADENT, INC. 510(k) NO: K042847(TRADITIONAL)
ATTN: DONNA M HARTNETT PHONE NO : 716-691-2260
175 PINEVIEW DR. SE DECISION MADE: 17-DEC-04
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: WILLI GELLER CREATION CP PORCELAIN
JENSEN INDUSTRIES, INC. 510(k) NO: K043221(TRADITIONAL)
ATTN: GARY PHELPS PHONE NO : 203-239-2090
50 STILLMAN RD. SE DECISION MADE: 20-DEC-04
NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KA
KAMIYA BIOMEDICAL CO. 510(k) NO: K042241(TRADITIONAL)
ATTN: BRIAN SCHLIESMAN PHONE NO : 206-575-8068
12779 GATEWAY DR. SE DECISION MADE: 10-DEC-04
SEATTLE, WA 98168 510(k) STATEMENT
DEVICE: KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL
KENDALL 510(k) NO: K042461(ABBREVIATED)
ATTN: PAUL W EVANS PHONE NO : 508-261-8203
15 HAMPSHIRE ST. SE DECISION MADE: 10-DEC-04
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SY
KENDALL 510(k) NO: K043272(SPECIAL)
ATTN: JIM WELSH PHONE NO : 508-261-8532
15 HAMPSHIRE ST. SE DECISION MADE: 22-DEC-04
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE
KIMBERLY-CLARK CORP. 510(k) NO: K043114(SPECIAL)
ATTN: S. MCMILLAN PHONE NO : 801-523-5295
12050 LONE PEAK PARKWAY SE DECISION MADE: 10-DEC-04
DRAPER, UT 84020 510(k) STATEMENT
DEVICE: DIRECT DIGITIZER, REGIUS MODEL 190
KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K042386(SPECIAL)
ATTN: SHINICHI YAMANAKA PHONE NO : 81 596 370190
PROGRESS SECTION SE DECISION MADE: 15-DEC-04
319 AKENO, OBATA-CHO 510(k) SUMMARY AVAILABLE FROM FDA
WATARAI-GUN; MIE-KEN, JAPAN 519-05
DEVICE: KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KI
KRONUS MARKET DEVELOPMENT ASSOCIAT510(k) NO: K042248(TRADITIONAL)
ATTN: HEATHER VIELE PHONE NO : 208-377-4800
12554 WEST BRIDGER ST. SE DECISION MADE: 17-DEC-04
SUITE 108 510(k) STATEMENT
BOISE, ID 83713
DEVICE: CLEAFIL DC CORE AUTOMIX
KURARAY MEDICAL INC. 510(k) NO: K043177(TRADITIONAL)
ATTN: SATOSHI YAMAGUCHI PHONE NO : 212-986-2230
101 EAST 52ND STREET, 26TH FL. SE DECISION MADE: 17-DEC-04
NEW YORK, NY 10022 510(k) STATEMENT
DEVICE: ESTENIA C&B
KURARAY MEDICAL KURASHIKI PLANT 510(k) NO: K042929(TRADITIONAL)
ATTN: KOJI NISHIDA PHONE NO : 212-986-2230
101 EAST 52ND STREET SE DECISION MADE: 06-DEC-04
26TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10022
DEVICE: PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49,
LEMAITRE VASCULAR, INC. 510(k) NO: K043023(SPECIAL)
ATTN: SABA MODJARRAD PHONE NO : 781-221-2266
63 2ND AVENUE SE DECISION MADE: 03-DEC-04
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENTLEWAVES LED PHOTOMODULATION DEVICE
LIGHT BIOSCIENCE, LLC 510(k) NO: K031425(TRADITIONAL)
ATTN: ROBERT T HANDREN, JR. PHONE NO : 352-314-8829
5818 PRIONCESS CAROLINE PLACE SE DECISION MADE: 15-DEC-04
LEESBURG, FL 34748 510(k) STATEMENT
DEVICE: OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM
LUMENIS LTD. 510(k) NO: K040270(TRADITIONAL)
ATTN: ANDREA L RUTH PHONE NO : 408-764-3235
2400 CONDENSA STREET SE DECISION MADE: 16-DEC-04
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUTH-ALL SUB-Q NEEDLE SET
LUTH-ALL MEDICAL PRODUCTS, LLC 510(k) NO: K042666(TRADITIONAL)
ATTN: SHEPARD G BENTLEY PHONE NO : 949-365-5790
28303 CABOT RD. SUITE 300 SE DECISION MADE: 21-DEC-04
LAGUNA NIGUEL, CA 92677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR
MARS MEDICAL PRODUCTS CO., LTD. 510(k) NO: K032825(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 10-DEC-04
CROFTON, MD 21114-4341 510(k) STATEMENT
DEVICE: UNIVERSAL XACTTRACE
MEDCARE FLAGA 510(k) NO: K043132(TRADITIONAL)
ATTN: KOLBRUN E OTTOSDOTTIR PHONE NO : 011 354 5102000
SIDUMULI 24 SE DECISION MADE: 21-DEC-04
REYKJAVIK, ICELAND IS 108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANA
MEDICAL IMAGING APPLICATIONS LLC 510(k) NO: K033266(TRADITIONAL)
ATTN: MILAN SONKA PHONE NO : 319-358-1529
832 FOREST HILL DR SE DECISION MADE: 16-DEC-04
CORALVILLE, IA 52241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METRX WORKSTATION
MEDICAL METRX SOLUTIONS, INC. 510(k) NO: K043134(TRADITIONAL)
ATTN: PATSY J TRISLER PHONE NO : 301-652-5344
5610 WISCONSIN AVENUE,#304 SE DECISION MADE: 13-DEC-04
CHEVY CHASE, MD 20815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM
MEDISON CO., LTD. 510(k) NO: K043455(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 21-DEC-04
CORINTH, TX 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM
MEDRAD, INC. 510(k) NO: K042784(SPECIAL)
ATTN: JOHN M KISTE PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 10-DEC-04
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL
MEDTRADE PRODUCTS LTD. 510(k) NO: K033732(TRADITIONAL)
ATTN: JONATHAN D RANFIELD PHONE NO : 440 127 0500019
ELECTRA HOUSE SE DECISION MADE: 01-DEC-04
CREWE BUSINESS PARK CREWE 510(k) SUMMARY AVAILABLE FROM FDA
CHESHIRE, UNITED KINGDOM CW1 6GL
DEVICE: VERTEX RECONSTRUCTION SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K042789(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 21-DEC-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K042962(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 14-DEC-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K043343(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 28-DEC-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VERTE-STACK SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K043561(SPECIAL)
ATTN: RICHARD A TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 29-DEC-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6F Z4 GUIDE CATHETER
MEDTRONIC, INC. 510(k) NO: K042489(SPECIAL)
ATTN: FRED L BOUCHER PHONE NO : 978-777-0042
37A CHERRY HILL DR. SE DECISION MADE: 13-DEC-04
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
MEDTRONIC, INC. 510(k) NO: K043080(SPECIAL)
ATTN: BRUCE BACKLUND PHONE NO : 763-391-9000
7611 NORTHLAND DR. SE DECISION MADE: 03-DEC-04
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 6088
MEDTRONIC, INC. 510(k) NO: K043291(SPECIAL)
ATTN: DAVID D COX PHONE NO : 763-391-9251
7601 NORTHLAND DR. SE DECISION MADE: 21-DEC-04
MINNEAPOLIS, MN 55428 510(k) STATEMENT
DEVICE: PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000
MICRO MEDICAL DEVICES, INC. 510(k) NO: K043287(TRADITIONAL)
ATTN: RAFI ISRAEL PHONE NO : 818-874-0000
5308 DERRY AVE., SUITE I-204 SE DECISION MADE: 10-DEC-04
AGOURA HILLS, CA 91301 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K043110(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 09-DEC-04
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ML830 LASER SYSTEM
MICROLIGHT CORPORATION OF AMERICA 510(k) NO: K041364(TRADITIONAL)
ATTN: FRED A SIMPSON PHONE NO : 713-752-4248
1401 MCKINNEY ST. SE DECISION MADE: 13-DEC-04
SUITE 1900 510(k) SUMMARY AVAILABLE FROM FDA
HOUSTON, TX 77010
DEVICE: SCENIUM
MIRADA SOLUTIONS LTD 510(k) NO: K042863(TRADITIONAL)
ATTN: MARIA EBIO PHONE NO : 865-218-2534
810 INNOVATION DRIVE SE DECISION MADE: 15-DEC-04
KNOXVILLE, TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS
MSQ (M2) LTD. 510(k) NO: K042000(TRADITIONAL)
ATTN: ANNE WORDEN PHONE NO : 925-895-1200
3637 BERNAL AVENUE SE DECISION MADE: 21-DEC-04
PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTF ALLOGRAFT ANCHOR
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K042038(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE SE DECISION MADE: 23-DEC-04
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR
NELLCOR PURITAN BENNETT, INC. 510(k) NO: K033973(TRADITIONAL)
ATTN: LUANNE NG PHONE NO : 925-463-4348
4280 HACIENDA DR. SE DECISION MADE: 13-DEC-04
PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOSCI MEDICAL ENDOLUMINAL BRUSH
NEOSCI MEDICAL, INC. 510(k) NO: K030400(TRADITIONAL)
ATTN: PHIL TRIOLO PHONE NO : 801-328-1996
148 S. 1200 E. SE DECISION MADE: 22-DEC-04
SALT LAKE CITY, UT 84102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEWPORT C250 AIR COMPRESSOR MODEL C250
NEWPORT MEDICAL INSTRUMENTS 510(k) NO: K041406(TRADITIONAL)
ATTN: RICHARD WATERS PHONE NO : 949-642-3910
760 W 16TH STREET, BLDG. N SE DECISION MADE: 15-DEC-04
COSTA MESA, CA 92627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTWAVE MS 2000
NEWWAVE MEDICAL LLC 510(k) NO: K041063(TRADITIONAL)
ATTN: ROBERT ARMSTRONG PHONE NO : 972-516-8383
620 HAGGARD STREET SE DECISION MADE: 01-DEC-04
STE. 614 510(k) SUMMARY AVAILABLE FROM FDA
PLANO, TX 75074
DEVICE: NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN
NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K042676(TRADITIONAL)
ATTN: XIE QIYL PHONE NO : 949-940-7358
1311 CALLE BATIDO SE DECISION MADE: 17-DEC-04
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NICHOLS ADVANTAGE CORTISOL
NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K042689(TRADITIONAL)
ATTN: JIMMY WONG PHONE NO : 949-940-7260
1311 CALLE BATIDO SE DECISION MADE: 09-DEC-04
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300
NIDEK, INC. 510(k) NO: K042785(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LN. SE DECISION MADE: 14-DEC-04
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC)
NITI MEDICAL TECHNOLOGIES LTD. 510(k) NO: K043115(TRADITIONAL)
ATTN: ORLY MAOR PHONE NO : 972 9 8650610
1 HATZORAN ST. SE DECISION MADE: 01-DEC-04
P.O. BOX 8634 510(k) SUMMARY AVAILABLE FROM FDA
NETANYA, ISRAEL 42506
DEVICE: TCM ENDO V, MODEL 1534
NOUVAG AG 510(k) NO: K042822(TRADITIONAL)
ATTN: ERICH FORSTER PHONE NO : 004 156 2019500
REUSSWEHRSTRASSE 1 SE DECISION MADE: 22-DEC-04
GEBENSTORF, SWITZERLAND 5412 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOUVAG AG - VACUSON 40 AND VACUSON 60
NOUVAG AG 510(k) NO: K042943(TRADITIONAL)
ATTN: ERICH FORSTER PHONE NO : 41 56 2019500
REUSSWEHRSTRASSE 1 SE DECISION MADE: 17-DEC-04
GEBENSTORF, SWITZERLAND 5412 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES
NOVALIS MEDICAL, LLC 510(k) NO: K043319(TRADITIONAL)
ATTN: ANTHONY DAVIS PHONE NO : 813-849-6362
1719 W. KENNEDY BLVD. SE DECISION MADE: 17-DEC-04
TAMPA, FL 33606 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OSS/(SCARF)- AND OSW-SCREW
O.M.T. OBERFLACHEN-UND MATERIALTEC510(k) NO: K042079(TRADITIONAL)
ATTN: H. DARREL DARBY II PHONE NO : 800-999-8866
1327 7TH AVENUE SE DECISION MADE: 20-DEC-04
HUNTINGTON, WV 25701 510(k) STATEMENT
DEVICE: OLYMPUS LACTATE, OSR6193
OLYMPUS AMERICA, INC. 510(k) NO: K042406(TRADITIONAL)
ATTN: BEV HARDING PHONE NO : 800-628-7152
3131 WEST ROYAL LN. SE DECISION MADE: 03-DEC-04
IRVING, TX 75063-3104 510(k) STATEMENT
DEVICE: OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279
OLYMPUS AMERICA, INC. 510(k) NO: K043202(TRADITIONAL)
ATTN: BEV HARDING PHONE NO : 972-556-9697
3131 WEST ROYAL LN. SE DECISION MADE: 23-DEC-04
IRVING, TX 75063-3104 510(k) STATEMENT
DEVICE: OLYMPUS ENDOARM
OLYMPUS CORPORATION 510(k) NO: K043128(TRADITIONAL)
ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 21-DEC-04
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K043275(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DR. SE DECISION MADE: 09-DEC-04
MELVILLE, NY 11747-9058 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT
ONYX MEDICAL INC. 510(k) NO: K041679(ABBREVIATED)
ATTN: ROGER MACHSON PHONE NO : 415-331-0193
445 COLOMA STREET SE DECISION MADE: 16-DEC-04
SAUSALITO, CA 94965 510(k) STATEMENT
DEVICE: OPUS MINIMAGNUM ANCHOR WITH INSERTER
OPUS MEDICAL, INC. 510(k) NO: K042584(TRADITIONAL)
ATTN: LAURA N KASPEROWICZ PHONE NO : 949-234-0400
27127 CALLE ARROYO, SUITE 1924 SE DECISION MADE: 14-DEC-04
SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K042476(TRADITIONAL)
ATTN: CAREY A MAYO PHONE NO : 585-453-3482
100 INDIGO CREEK DR. SE DECISION MADE: 01-DEC-04
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PR
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K042838(TRADITIONAL)
ATTN: DARLENE J PHILLIPS PHONE NO : 585-453-4253
100 INDIGO CREEK DR. SE DECISION MADE: 09-DEC-04
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
OSTEOBIOLOGICS, INC. 510(k) NO: K040047(TRADITIONAL)
ATTN: GABRIELE G NIEDERAUER PHONE NO : 210-690-2131
12500 NETWORK SE DECISION MADE: 17-DEC-04
SUITE 112 510(k) SUMMARY AVAILABLE FROM FDA
SAN ANTONIO, TX 78249
DEVICE: MODIFICATION TO: PLEXALONG SETS
PAJUNK GMBH 510(k) NO: K042979(SPECIAL)
ATTN: BURK A BRANDT PHONE NO : 541-752-3953
5010 NW CRESCENT VALLEY DR. SE DECISION MADE: 21-DEC-04
CORVALLIS, OR 97330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS
PAJUNK GMBH 510(k) NO: K043130(SPECIAL)
ATTN: BURK A BRANDT PHONE NO : 541-752-3953
5101 NW CRESCENT VALLEY DR. SE DECISION MADE: 21-DEC-04
CORVALLIS, OR 97330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEEDLE INCAPACITATOR (NEEDLE GUARD)
PDMP, INC. 510(k) NO: K042907(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 22-DEC-04
CROFTON, MD 21114 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: PEFAKIT APC-R FACTOR V LEIDEN CONTROLS
PENTAPHARM LTD. 510(k) NO: K042760(ABBREVIATED)
ATTN: M. ELISABETH BIERMAN PHONE NO : 202-739-5206
1111 PENNSYLVANIA AVE., NW SE DECISION MADE: 22-DEC-04
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEFAKIT APC-R FACTOR V LEIDEN
PENTAPHARM LTD. 510(k) NO: K042762(TRADITIONAL)
ATTN: M. ELISABETH BIERMAN PHONE NO : 202-739-5206
1111 PENNSYLVANIA AVE., NW SE DECISION MADE: 22-DEC-04
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON
PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K042805(TRADITIONAL)
ATTN: KK LEONG PHONE NO : 603 329 11949
LOT 754, JALAN HAJI SIRAT SE DECISION MADE: 16-DEC-04
KLANG, SELANGOR, MALAYSIA 42100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9
PHAMATECH INC. 510(k) NO: K043167(SPECIAL)
ATTN: CARL MONGIOVI PHONE NO : 858-643-5555
10151 BARNES CANYON RD SE DECISION MADE: 29-DEC-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD
PHONIC EAR, INC. 510(k) NO: K043090(TRADITIONAL)
ATTN: TODD BISSEY PHONE NO : 707-769-1110
3880 CYPRESS DR. SE DECISION MADE: 23-DEC-04
PETALUMA, CA 94954-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015
PROGENY, INC. 510(k) NO: K043092(TRADITIONAL)
ATTN: ALAN KREMA PHONE NO : 847-850-3800
1407 BARCLAY BLVD. SE DECISION MADE: 13-DEC-04
BUFFALO GROVE, IL 60089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROMEDICAL SURGICAL GOWNS
PROMEDICAL PRODUCTS CO., LTD. 510(k) NO: K042111(TRADITIONAL)
ATTN: BOYD HARRIS PHONE NO : 662-352-1910
125 CLEMENTS AVE. SE DECISION MADE: 10-DEC-04
STARKVILLE, MS 39759 510(k) STATEMENT
DEVICE: PROMEDICAL SURGICAL DRAPES
PROMEDICAL PRODUCTS CO., LTD. 510(k) NO: K042131(TRADITIONAL)
ATTN: BOYD HARRIS PHONE NO : 662-352-1910
125 CLEMENTS AVE. SE DECISION MADE: 10-DEC-04
STARKVILLE, MS 39759 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE
PT. MANDIRI INTI BUANA 510(k) NO: K042239(TRADITIONAL)
ATTN: P. SASITHARAN NAIR PHONE NO : 62 61 7944880
JALAN SEI BELUMAI SE DECISION MADE: 16-DEC-04
DESA DALU 10 A DUSUN 1 510(k) SUMMARY AVAILABLE FROM FDA
TANJUNG MORAWA, SUMUT, INDONESIA 20362
DEVICE: POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION
PT. MEDISAFE TECHNOLOGIES 510(k) NO: K041913(TRADITIONAL)
ATTN: ANIL TANEJA PHONE NO : 62 061 7941463
GG. TAMBAK REJO SE DECISION MADE: 01-DEC-04
DESA BUNTU BEDIMBAR 510(k) STATEMENT
TANJUNG MORAWA, MEDAN, INDONESIA 20362
DEVICE: TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPA
RETINAPHARMA TECHNOLOGIES INC. 510(k) NO: K042099(TRADITIONAL)
ATTN: TERRY A FULLER, PH.D. PHONE NO : 215-885-4558
944 MORGAN ROAD SE DECISION MADE: 10-DEC-04
JENKINTOWN, PA 19046 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SHORT INTRODUCER SHEATH
REX MEDICAL LP 510(k) NO: K042399(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD. SE DECISION MADE: 17-DEC-04
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: ONLINE DAT BARBITURATES PLUS
ROCHE DIAGNOSTICS CORP. 510(k) NO: K043211(TRADITIONAL)
ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637
9115 HAGUE RD. SE DECISION MADE: 29-DEC-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY
ROCHE DIAGNOSTICS CORP. 510(k) NO: K043318(SPECIAL)
ATTN: KAY A TAYLOR PHONE NO : 317-521-3544
9115 HAGUE RD. SE DECISION MADE: 23-DEC-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II
ROCHE DIAGNOSTICS CORP. 510(k) NO: K043320(SPECIAL)
ATTN: KAY A TAYLOR PHONE NO : 317-521-3544
9115 HAGUE RD. SE DECISION MADE: 17-DEC-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTECTION PLUS EARLOOP PROCEDURE MASK
SAFETY-MED PRODUCTS, INC. 510(k) NO: K042654(TRADITIONAL)
ATTN: CHRIS WAGNER PHONE NO : 262-767-9674
140 LONGMEADOW DRIVE SE DECISION MADE: 17-DEC-04
BURLINGTON, WI 53105 510(k) STATEMENT
DEVICE: ULTRALIGHT II ND:YAG LASER SYSTEM
SANDSTONE MEDICAL TECHNOLOGIES, LL510(k) NO: K041011(TRADITIONAL)
ATTN: CONNIE WHITE HOY PHONE NO : 530-666-7616
908 STETSON STREET SE DECISION MADE: 14-DEC-04
WOODLAND, CA 95776 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IS 40 MICROMOTOR
SATELEC 510(k) NO: K042787(TRADITIONAL)
ATTN: STEVE SALESKY PHONE NO : 856-222-9988
130 GAITHER DRIVE SE DECISION MADE: 17-DEC-04
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
MT. LAUREL, NJ 08054
DEVICE: MX POLYAXIAL PEDICLE SCREW
SCIENT'X 510(k) NO: K043001(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 01-DEC-04
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UCR SPINAL SYSTEM
SEASPINE 510(k) NO: K043232(TRADITIONAL)
ATTN: DIANA SMITH PHONE NO : 760-727-8399
2303 LA MIRADA DRIVE SE DECISION MADE: 21-DEC-04
VISTA, CA 92081-7862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE CLEAR SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MED
SHIJAIZHUANG BRILLIANT OCEAN PLAST510(k) NO: K043159(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 909-591-8855
5445 DANIELS STREET SE DECISION MADE: 20-DEC-04
CHINO, CA 91710 510(k) STATEMENT
DEVICE: SHIMADZU COLLIMATOR R-20J
SHIMADZU CORP. 510(k) NO: K042840(ABBREVIATED)
ATTN: RANDAL WALKERI PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVE. SE DECISION MADE: 03-DEC-04
TORRANCE, CA 90502-1328 510(k) STATEMENT
DEVICE: MEGNETOM C! MR SYSTEM
SIEMENS MEDICAL SOLUTIONS 510(k) NO: K043030(TRADITIONAL)
ATTN: NEALIE HARTMAN PHONE NO : 610-448-1769
51 VALLEY STREAM PARKWAY E50 SE DECISION MADE: 09-DEC-04
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM RESPIRATORY GATING
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K043086(TRADITIONAL)
ATTN: DEBBIE PEACOCK PHONE NO : 610-448-1769
51 VALLEY STREAM PKWY. SE DECISION MADE: 23-DEC-04
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM CARE CONTRAST CT
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K043087(TRADITIONAL)
ATTN: DEBBIE PEACOCK PHONE NO : 610-448-1773
51 VALLEY STREAM PKWY. SE DECISION MADE: 15-DEC-04
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVE
SINTEA BIOTECH, INC. 510(k) NO: K043355(SPECIAL)
ATTN: GUIDO ZORZOLI PHONE NO : 305-673-6226
407 LINCOLN RD. SUITE 10L SE DECISION MADE: 17-DEC-04
MIAMI BEACH, FL 33139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND
SONOSITE,INC. 510(k) NO: K043452(TRADITIONAL)
ATTN: DAINA L GRAHAM PHONE NO : 425-951-1275
21919 30TH DRIVE SE. SE DECISION MADE: 21-DEC-04
BOTHELL, WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-30
SOPHYSA SA 510(k) NO: K042481(TRADITIONAL)
ATTN: JACKIE MASSE PHONE NO : 781-239-8108
70 WALNUT ST. SE DECISION MADE: 14-DEC-04
WELLESLEY, MA 02481 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRANEX D
SOREDEX INSTRUMENTARIUM CORP. 510(k) NO: K043307(TRADITIONAL)
ATTN: KAI LANER PHONE NO : 358 103 94820
NAHKELANTIE 160 SE DECISION MADE: 17-DEC-04
TUUSULA, FINLAND 00430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM
SOURCE-RAY, INC. 510(k) NO: K043062(TRADITIONAL)
ATTN: RAY MANEZ PHONE NO : 631-244-8200
167 KEYLAND CT. SE DECISION MADE: 13-DEC-04
BOHEMIA, NY 11716 510(k) STATEMENT
DEVICE: RIVA SILVER
SOUTHERN DENTAL INDUSTRIES, INC. 510(k) NO: K042452(TRADITIONAL)
ATTN: SAMANTHA J CHEETHAM PHONE NO : 630-238-8300
729 N. ROUTE 83, SUITE 315 SE DECISION MADE: 07-DEC-04
BENSENVILLE, IL 60106 510(k) STATEMENT
DEVICE: FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5
SPINE NEXT AMERICA CORPORATION 510(k) NO: K042713(TRADITIONAL)
ATTN: TOM BREWER PHONE NO : 904-363-3448
8381 DIX ELLIS TRAIL, STE. 110 SE DECISION MADE: 29-DEC-04
JACKSONVILLE, FL 32256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4
SPINE NEXT AMERICA CORPORATION 510(k) NO: K042714(TRADITIONAL)
ATTN: TOM BREWER PHONE NO : 904-363-3448
8381 DIX ELLIS TRAIL, STE. 110 SE DECISION MADE: 29-DEC-04
JACKSONVILLE, FL 32256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEDIGUARD NERVE DETECTOR SYSTEM
SPINEVISION, INC. 510(k) NO: K030526(TRADITIONAL)
ATTN: LYNNETTE WHITAKER PHONE NO : 574-269-9776
3003 SUMMIT BLVD. SE DECISION MADE: 29-DEC-04
SUITE 1400 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30319
DEVICE: SPACEVISION CAGE SYSTEM
SPINEVISION, INC. 510(k) NO: K042930(TRADITIONAL)
ATTN: LYNETTE WHITAKER PHONE NO : 574-269-9776
3003 SUMMIT BLVD. STE 1400 SE DECISION MADE: 28-DEC-04
ATLANTA, GA 30319 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARAT
SPIRE BIOMEDICAL, INC. 510(k) NO: K042858(TRADITIONAL)
ATTN: DONALD FICKETT PHONE NO : 781-275-6001
ONE PATRIOTS PARK SE DECISION MADE: 03-DEC-04
BEDFORD, MA 01730-2396 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SJM RIGID SADDLE RING MODEL RSAR-(SIZE)
ST. JUDE MEDICAL, INC. 510(k) NO: K042734(TRADITIONAL)
ATTN: WILLIAM MCKELVEY PHONE NO : 651-415-7029
ONE LILLEHEI PLAZA SE DECISION MADE: 17-DEC-04
ST. PAUL, MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STARION UNIVERSAL POWER SUPPLY (UPS)
STARION INSTRUMENTS 510(k) NO: K043155(SPECIAL)
ATTN: BRIAN GRIGSBY PHONE NO : 408-741-8773
20665 4TH ST. SE DECISION MADE: 09-DEC-04
SARATOGA, CA 95070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERFAS ENERGY SYSTEM
STRYKER ENDOSCOPY 510(k) NO: K041810(TRADITIONAL)
ATTN: CHRISTINE REISTETTER PHONE NO : 408-754-2229
5900 OPTICAL CT. SE DECISION MADE: 21-DEC-04
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: STRYKER CASSETTE PUMP
STRYKER ENDOSCOPY 510(k) NO: K042454(TRADITIONAL)
ATTN: CHRISTOPHER L COOK PHONE NO : 408-754-2288
5900 OPTICAL CT. SE DECISION MADE: 09-DEC-04
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERBERT ULNAR HEAD PROSTHESIS SYSTEM
STUCKENBROCK MEDIZINTECHNIK GMBH 510(k) NO: K042902(TRADITIONAL)
ATTN: AL WEISENBORN PHONE NO : 305-829-3437
12244 SW 130 ST. SE DECISION MADE: 27-DEC-04
MIAMI, FL 33186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR FOREHEAD/BROWLIFT THREAD
SURGICAL SPECIALTIES CORP. 510(k) NO: K042856(TRADITIONAL)
ATTN: ELIZABETH LAZARO PHONE NO : 800-523-3332
100 DENNIS DR. SE DECISION MADE: 03-DEC-04
READING, PA 19606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARELISA SM ANTIBODIES, MODEL 18296
SWEDEN DIAGNOSTICS (GERMANY) GMBH 510(k) NO: K042629(TRADITIONAL)
ATTN: SABINE KLUGBAUER PHONE NO : 497 614 7805419
MUNZINGER STRASSE 7 SE DECISION MADE: 08-DEC-04
FREIBURG, GERMANY D-79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER
TAKARA BELMONT USA, INC. 510(k) NO: K041834(TRADITIONAL)
ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830
1129 BLOOMFIELD AVENUE SE DECISION MADE: 03-DEC-04
WEST CALDWELL, NJ 07006 510(k) STATEMENT
DEVICE: TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X
TANITA CORP. OF AMERICA 510(k) NO: K040778(TRADITIONAL)
ATTN: RHODA LYNN VALERA PHONE NO : 847-434-3966
2625 SOUTH CLEARBROOK DR. SE DECISION MADE: 23-DEC-04
ARLINGTON HGTS., IL 60005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISIOPLAST ACRYLIC RESIN
TECRES 510(k) NO: K042414(TRADITIONAL)
ATTN: CHRISTINE BRAUER PHONE NO : 301-545-1990
ONE DEMOCRACY PLAZA SE DECISION MADE: 29-DEC-04
6701 DEMOCRACT BLVD. STE. 700 510(k) SUMMARY AVAILABLE FROM FDA
BETHESDA, MD 20817
DEVICE: CEMENTEK LV
TEKNIMED SA 510(k) NO: K042911(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 27-DEC-04
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T46
TELEFLEX MEDICAL 510(k) NO: K043258(SPECIAL)
ATTN: SUSAN KAGAN PHONE NO : 508-677-6675
50 PLANTATION DRIVE SE DECISION MADE: 16-DEC-04
TALL PINES PARK 510(k) SUMMARY AVAILABLE FROM FDA
JAFFERY, NH 03452
DEVICE: TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES
TERATECH CORP. 510(k) NO: K043278(TRADITIONAL)
ATTN: CHARLES F HOTTINGER PHONE NO : 206-780-7945
PO BOX 10074 SE DECISION MADE: 13-DEC-04
13221 NE TEEM LOOP ROAD 510(k) SUMMARY AVAILABLE FROM FDA
BAINBRIDGE ISLAND, WA 98110 THIRD PARTY REVIEW
DEVICE: SONATA 3-D IMAGING ACCESSORY, MODEL 3DS
TETRAD CORP. 510(k) NO: K042620(TRADITIONAL)
ATTN: DENNIS R DIETZ PHONE NO : 303-754-2320
357 INVERNESS DR. SOUTH, SE DECISION MADE: 23-DEC-04
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
ENGLEWOOD, CO 80112
DEVICE: ANSPACH "MINIMAL ACCESS SPINAL ATTACHMENT" (MASA) SYSTEM
THE ANSPACH EFFORT, INC. 510(k) NO: K042783(TRADITIONAL)
ATTN: WILLIAM G CONETY PHONE NO : 561-627-1080
4500 RIVERSIDE DR. SE DECISION MADE: 17-DEC-04
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MD-6W WIRELESS CRITICAL DATA VIEWER
THE MICROOPTICAL CORPORATION 510(k) NO: K042923(TRADITIONAL)
ATTN: DANIEL J DILLON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 17-DEC-04
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERMACOL SURGICAL IMPLANT
TISSUE SCIENCE LABORATORIES, PLC 510(k) NO: K043366(TRADITIONAL)
ATTN: VICTORIA TAYLOR PHONE NO : 678-342-7808
1141 CLARK STREET, SUITE D SE DECISION MADE: 17-DEC-04
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORAYGUIDE GUIDEWIRE
TORAY INDUSTRIES (AMERICA), INC. 510(k) NO: K042370(TRADITIONAL)
ATTN: LISA S JONES PHONE NO : 713-664-6775
540 COLLEGE ST. SE DECISION MADE: 17-DEC-04
BELLAIRE, TX 77401-5010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOU
TORNIER S.A. 510(k) NO: K043077(TRADITIONAL)
ATTN: LEMERY MIREILLE PHONE NO : 33 476 613898
161 RUE LAVOISIER SE DECISION MADE: 17-DEC-04
MONTBONNOT, SAINT-ISMIER, FRANCE 3510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANS1 AXIAL FIXATION SYSTEM
TRANS1, INC. 510(k) NO: K040426(TRADITIONAL)
ATTN: CHERYL L JOHNS PHONE NO : 910-509-3100
1800 SIR TYLER DRIVE SE DECISION MADE: 17-DEC-04
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
WILMINGTON, NC 28405
DEVICE: ULTRADENT CARBON MASK - UPI #342
ULTRADENT PRODUCTS, INC. 510(k) NO: K041047(ABBREVIATED)
ATTN: TAMMY LAVERY PHONE NO : 800-552-5513
505 WEST 10200 SOUTH SE DECISION MADE: 01-DEC-04
SOUTH JORDAN, UT 84095 510(k) STATEMENT
DEVICE: AMELOGEN PLUS
ULTRADENT PRODUCTS, INC. 510(k) NO: K043119(SPECIAL)
ATTN: TAMMY LAVERY PHONE NO : 801-553-4323
505 WEST 10200 SOUTH SE DECISION MADE: 17-DEC-04
SOUTH JORDAN, UT 84095 510(k) STATEMENT
DEVICE: UNISILK
UNITED MEDICAL INDUSTRIES CO. LTD.510(k) NO: K042282(TRADITIONAL)
ATTN: MOHAMMED AZEEZ PHONE NO : 009 661 2650665
3RD INDUSTRIAL CITY SE DECISION MADE: 01-DEC-04
SANAYYA, OPPOSITE TO OBAIKAN 510(k) STATEMENT
RIYADH, CENTRAL PROVINCE, SAUDI ARABIA 11553
DEVICE: UNIPRO
UNITED MEDICAL INDUSTRIES CO. LTD.510(k) NO: K042283(TRADITIONAL)
ATTN: MOHAMMED AZEEZ PHONE NO : 009 661 2650665
3RD INDUSTRIAL CITY SE DECISION MADE: 01-DEC-04
SANAYYA, OPPOSITE TO OBAIKAN 510(k) STATEMENT
RIYADH, CENTRAL PROVINCE, SAUDI ARABIA 11553
DEVICE: UNIMIDE
UNITED MEDICAL INDUSTRIES CO. LTD.510(k) NO: K042284(TRADITIONAL)
ATTN: MOHAMMED AZEEZ PHONE NO : 009 661 2650665
3RD INDUSTRIAL CITY SE DECISION MADE: 03-DEC-04
SANAYYA, OPPOSITE TO OBAIKAN 510(k) STATEMENT
RIYADH, CENTRAL PROVINCE, SAUDI ARABIA 11553
DEVICE: UNICRYL M
UNITED MEDICAL INDUSTRIES CO. LTD.510(k) NO: K042285(TRADITIONAL)
ATTN: MOHAMMED AZEEZ PHONE NO : 009 661 2650665
3RD INDUSTRIAL CITY SE DECISION MADE: 10-DEC-04
SANAYYA, OPPOSITE TO OBAIKAN 510(k) STATEMENT
RIYADH, CENTRAL PROVINCE, SAUDI ARABIA 11553
DEVICE: UNIESTER C
UNITED MEDICAL INDUSTRIES CO. LTD.510(k) NO: K042286(TRADITIONAL)
ATTN: MOHAMMED AZEEZ PHONE NO : 009 661 2650665
3RD INDUSTRIAL CITY SE DECISION MADE: 01-DEC-04
SANAYYA, OPPOSITE TO OBAIKAN 510(k) STATEMENT
RIYADH, CENTRAL PROVINCE, SAUDI ARABIA 11553
DEVICE: UNICRYL
UNITED MEDICAL INDUSTRIES CO. LTD.510(k) NO: K042288(TRADITIONAL)
ATTN: MOHAMMED AZEEZ PHONE NO : 009 661 2650665
3RD INDUSTRIAL CITY SE DECISION MADE: 27-DEC-04
SANAYYA, OPPOSITE TO OBAIKAN 510(k) STATEMENT
RIYADH, CENTRAL PROVINCE, SAUDI ARABIA 11553
DEVICE: VASCULAR SOLUTIONS SCLERO-KIT
VASCULAR SOLUTIONS, INC. 510(k) NO: K043019(TRADITIONAL)
ATTN: SARA L COON PHONE NO : 763-656-4399
6464 SYCAMORE COURT NORTH SE DECISION MADE: 01-DEC-04
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
VERTEBRON, INC. 510(k) NO: K043181(SPECIAL)
ATTN: LUIS NESPRIDO PHONE NO : 203-380-3940
400 LONG BEACH BLVD. SE DECISION MADE: 17-DEC-04
STRATFORD, CT 06615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORTRAK
VIASYS MEDSYSTEMS 510(k) NO: K041987(TRADITIONAL)
ATTN: STEPHANIE WASIELEWSKI PHONE NO : 847-353-1348
100 CHADDICK DR. SE DECISION MADE: 17-DEC-04
WHEELING, IL 60090 510(k) STATEMENT
DEVICE: VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM
VITAL IMAGES, INC. 510(k) NO: K043333(ABBREVIATED)
ATTN: TIMOTHY J KAPPERS PHONE NO : 763-852-6914
3300 FERNBROOK LN. NORTH SE DECISION MADE: 15-DEC-04
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, MN 55447 THIRD PARTY REVIEW
DEVICE: GORE POLYPROPYLENE HERNIA MESH
W. L. GORE & ASSOCIATES, INC. 510(k) NO: K043081(TRADITIONAL)
ATTN: MICHAEL IVEY PHONE NO : 928-864-3790
3450 WEST KILTIE LN. SE DECISION MADE: 22-DEC-04
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
W.L. GORE & ASSOCIATES,INC 510(k) NO: K043056(TRADITIONAL)
ATTN: BRANDON HANSON PHONE NO : 928-864-3784
3750 WEST KILTIE LN. SE DECISION MADE: 22-DEC-04
FLAGSTAFF, AZ 86002-0900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSERVE PLUS HA ACETABULAR SHELLS
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K042530(SPECIAL)
ATTN: JEANINE H REDDEN PHONE NO : 901-867-4522
5677 AIRLINE RD. SE DECISION MADE: 17-DEC-04
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700
YOUNG O/S LLC 510(k) NO: K042828(ABBREVIATED)
ATTN: STEPHEN W CONGER PHONE NO : 636-343-8300
1663 FENTON BUSINESS PARK CT. SE DECISION MADE: 01-DEC-04
FENTON, MO 63026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORPICALGIN
ZHERMACK S.P.A. 510(k) NO: K043131(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 15-DEC-04
BEND, OR 97702 510(k) STATEMENT
DEVICE: TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212
ZIMMER TRABECULAR 510(k) NO: K042871(SPECIAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 21-DEC-04
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIARTICULAR LOCKING PLATES, 2358 SERIES
ZIMMER, INC. 510(k) NO: K043227(SPECIAL)
ATTN: NOAH BARTSCH PHONE NO : 574-371-8552
P.O. BOX 708 SE DECISION MADE: 10-DEC-04
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 284
TOTAL WITH SUMMARIES 226
TOTAL WITH STATEMENTS 58
Updated January 5, 2005
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