510(k)s Final Decisions Rendered for October 2004

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510(k)s Final Decisions Rendered for October 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-OCT-2004 THROUGH 31-OCT-2004

 
DEVICE: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
3M COMPANY                        510(k) NO: K041934(TRADITIONAL)
ATTN: GINGER  CANTOR              PHONE NO : 651-736-2101
3M CENTER, BLDG. 275-5W-06        SE DECISION MADE: 15-OCT-04
ST. PAUL, MN 55144-1000           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYST
A.M. SURGICAL, INC.               510(k) NO: K042458(TRADITIONAL)
ATTN: CAROLANN  KOTULA            PHONE NO : 770-985-8203
55 NORTHERN BLVD.                 SE DECISION MADE: 07-OCT-04
SUITE 200                         510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021

DEVICE: XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODE
ABBOT LABORATORIES                510(k) NO: K041962(TRADITIONAL)
ATTN: JOANNA  KUSKOWSKI           PHONE NO : 650-474-3331
400 SAGINAW DR.                   SE DECISION MADE: 01-OCT-04
REDWOOD CITY, CA 94063            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERIFYNOW-ASPIRIN ASSAY
ACCUMETRICS, INC.                 510(k) NO: K042423(SPECIAL)
ATTN: BARBARA  STEVENS            PHONE NO : 858-404-8281
3985 SORRENTO VALLEY BLVD.        SE DECISION MADE: 06-OCT-04
SAN DIEGO, CA 92121               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUMED ANATOMIC RADIAL HEAD SYSTEM
ACUMED LLC                        510(k) NO: K041858(TRADITIONAL)
ATTN: ED  BOEHMER                 PHONE NO : 503-627-9957
5885 NW CORNELIUS PASS RD.        SE DECISION MADE: 05-OCT-04
HILLSBORO, OR 97124-9432          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUMEN SHEATH, MODEL TTW7807
ACUMEN MEDICAL, INC.              510(k) NO: K042376(TRADITIONAL)
ATTN: MARYBETH  GAMBER            PHONE NO : 650-352-5700
1400 TERRA BELLA BLVD.            SE DECISION MADE: 26-OCT-04
MOUNTAIN VIEW, CA 94043           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOSPECS
ADAC LABORATORIES                 510(k) NO: K042903(TRADITIONAL)
ATTN: JOY  SACMAR                 PHONE NO : 408-468-3053
540 ALDER DR.                     SE DECISION MADE: 29-OCT-04
MILPITAS, CA 95035                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: APNEA RISK EVALUATION SYSTEM (ARES)
ADVANCED BRAIN MONITORING, INC.   510(k) NO: K041662(TRADITIONAL)
ATTN: DANIEL J LEVENDOWSKI        PHONE NO : 760-720-0099
2850 PIO PICO DRIVE               SE DECISION MADE: 14-OCT-04
SUITE A                           510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92008

DEVICE: COMPLETE BLINK-N-CLEAN LENS DROPS
ADVANCED MEDICAL OPTICS, INC.     510(k) NO: K040839(ABBREVIATED)
ATTN: PAUL J NOWACKI              PHONE NO : 714-247-8609
1700 E. ST. ANDREW PLACE          SE DECISION MADE: 19-OCT-04
P.O. BOX 25162                    510(k) SUMMARY AVAILABLE FROM FDA
SANTA ANA, CA 92799-5162

 
DEVICE: MPM SYSTEM
AEROTEL MEDICAL SYSTEMS, LTD.     510(k) NO: K041854(TRADITIONAL)
ATTN: GEORGE  MYERS               PHONE NO : 201-737-1703
377 ROUTE 17 S                    SE DECISION MADE: 06-OCT-04
HASBROUCK HEIGHTS, NJ 07604       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AESKULISA DS DNA G
AESKU.DIAGNOSTICS                 510(k) NO: K041628(TRADITIONAL)
ATTN: STANLEY  AMMONS             PHONE NO : 703-860-5057
8880 NW 18TH TERRACE              SE DECISION MADE: 14-OCT-04
MIAMI, FL 33172                   510(k) STATEMENT

DEVICE: RADIOTHERAPY SOLUTION BASED ON CR
AGFA CORP.                        510(k) NO: K042779(TRADITIONAL)
ATTN: JEFFERY A JEDLICKA          PHONE NO : 864-421-1815
10 SOUTH ACADEMY ST.              SE DECISION MADE: 21-OCT-04
GREENVILLE, SC 29601              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SCANX 14
AIR TECHNIQUES, INC.              510(k) NO: K042397(SPECIAL)
ATTN: JOSEPH  CAREY               PHONE NO : 516-214-5541
70 CANTIAGUE ROCK RD.             SE DECISION MADE: 05-OCT-04
PO BOX 870                        510(k) STATEMENT
HICKSVILLE, NY 11802-0870

DEVICE: NOVEL VBR SPINAL SYSTEM
ALPHATEC/NEXMED                   510(k) NO: K042201(TRADITIONAL)
ATTN: ELLEN  YARNALL              PHONE NO : 760-431-9286
6110 CORTE DEL CEDRO              SE DECISION MADE: 07-OCT-04
CARLSBAD, CA 92009                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM
ALPHATEC/NEXMED                   510(k) NO: K042440(TRADITIONAL)
ATTN: ELLEN  YARNALL              PHONE NO : 760-431-9286
6110 CORTE DEL CEDRO              SE DECISION MADE: 07-OCT-04
CARLSBAD, CA 92009                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
ALPHATEC/NEXMED                   510(k) NO: K042673(SPECIAL)
ATTN: ELLEN A YARNALL             PHONE NO : 760-431-9286
6110 CORTE DEL CEDRO              SE DECISION MADE: 27-OCT-04
CARLSBAD, CA 92009                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND
AMERICAN BANTEX CORP.             510(k) NO: K041963(TRADITIONAL)
ATTN: TRACY S BEST                PHONE NO : 801-295-0748
994 NORTH MAIN STREET             SE DECISION MADE: 20-OCT-04
BOUNTIFUL, UT 84010               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMERICAN BANTEX, MODEL MS 3
AMERICAN BANTEX CORP.             510(k) NO: K042104(TRADITIONAL)
ATTN: TRACY S BEST                PHONE NO : 801-295-0748
994 NORTH MAIN STREET             SE DECISION MADE: 21-OCT-04
BOUNTIFUL, UT 84010               510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: VARI-ABLE APB (ADAPTABLE POSITIONING BASE)
AMERICAN TRACK ROADSTERS, INC.    510(k) NO: K042401(TRADITIONAL)
ATTN: GREG  PEEK                  PHONE NO : 303-986-9300
3535 SOUTH KIPLING STREET         SE DECISION MADE: 07-OCT-04
LAKEWOOD, CO 80235                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL DETECTOR, MODEL GR17
ANRAD CORP.                       510(k) NO: K042821(ABBREVIATED)
ATTN: DONALD J SHERRATT           PHONE NO : 978-977-3000
8 CENTENNIAL DRIVE                SE DECISION MADE: 22-OCT-04
PEABODY, MA 01960                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MODIFICATION TO URETERAL STENT
APPLIED MEDICAL RESOURCES CORP.   510(k) NO: K040760(SPECIAL)
ATTN: CHERYL  BLAKE               PHONE NO : 949-713-8327
22872 AVENIDA EMPRESSA            SE DECISION MADE: 15-OCT-04
RANCHO SANTA MARGARITA, CA 92688  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTRAVASCULAR ACCESS INTRODUCER SHEATH
APPLIED MEDICAL RESOURCES CORP.   510(k) NO: K041506(SPECIAL)
ATTN: CHERYL  BLAKE               PHONE NO : 949-713-8327
22872 AVENIDA EMPRESA             SE DECISION MADE: 15-OCT-04
RANCHO SANTA MARGARITA, CA 92688  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM
APPLIED MEDICAL TECHNOLOGY, INC.  510(k) NO: K042300(TRADITIONAL)
ATTN: CHRIS  ZANTOPULOS           PHONE NO : 216-475-5577
15653 NEO PKWY.                   SE DECISION MADE: 25-OCT-04
CLEVELAND, OH 44128               510(k) STATEMENT

DEVICE: FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST
ARMKEL LLC                        510(k) NO: K040866(TRADITIONAL)
ATTN: STEPHEN C KOLAKOWSKY        PHONE NO : 609-279-7748
469 NORTH HARRISON STREET         SE DECISION MADE: 19-OCT-04
PRINCETON, NJ 08543               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NYLON THREADED NEEDLE
AROS SURGICAL INSTRUMENTS CORP.   510(k) NO: K042367(ABBREVIATED)
ATTN: GRACE  HOLLAND              PHONE NO : 949-262-0411
3722 AVE. SAUSALITO               SE DECISION MADE: 14-OCT-04
IRVINE, CA 92606                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SILICONE COATED GUIDEWIRE
ARROW INTERNATIONAL, INC.         510(k) NO: K041740(TRADITIONAL)
ATTN: SUZANNE  SCHORLE            PHONE NO : 610-378-0131
2400 BERNVILLE RD.                SE DECISION MADE: 15-OCT-04
READING, PA 19612                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TI - SCREW ANCHOR SP
ARTHROTEK, INC.                   510(k) NO: K042460(TRADITIONAL)
ATTN: GARY  BAKER                 PHONE NO : 574-267-6639
56 EAST BELL DR.                  SE DECISION MADE: 29-OCT-04
P.O. BOX 587                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581

 
DEVICE: PRESS TACK NEEDLE
ASIA-MED GMBH & CO. KG. - WERK SUH510(k) NO: K042063(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720-962-5412
13 RED FOX LANE                   SE DECISION MADE: 14-OCT-04
LITTLETON, CO 80127               510(k) STATEMENT

DEVICE: AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHO
AXYA MEDICAL, INC.                510(k) NO: K041698(TRADITIONAL)
ATTN: HOWARD  SCHRAYER            PHONE NO : 978-232-9997
100 CUMMINGS CENTER               SE DECISION MADE: 05-OCT-04
SUITE 444C                        510(k) SUMMARY AVAILABLE FROM FDA
BEVERLY, MA 01915

DEVICE: PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET
B. BRAUN MEDICAL, INC.            510(k) NO: K041222(TRADITIONAL)
ATTN: LINDA  MORGAN               PHONE NO : 972-245-2243
1601 WALLACE DR., SUITE 150       SE DECISION MADE: 14-OCT-04
CARROLLTON, TX 75006              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING
B. BRAUN MEDICAL, INC.            510(k) NO: K041490(TRADITIONAL)
ATTN: JENNIFER A PUNG,            PHONE NO : 610-266-0500
901 MARCON BLVD.                  SE DECISION MADE: 29-OCT-04
ALLENTOWN, PA 18109-9341          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT
BARD ACCESS SYSTEMS, INC.         510(k) NO: K042445(TRADITIONAL)
ATTN: CHARLES  MORREALE           PHONE NO : 801-595-5534
5425 WEST AMELIA EARHART DR.      SE DECISION MADE: 19-OCT-04
SALT LAKE CITY, UT 84116          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: BAXJECT II
BAXTER HEALTHCARE CORP.           510(k) NO: K042410(ABBREVIATED)
ATTN: RON  LAGERQUIST             PHONE NO : 805-372-3064
ONE BAXTER WAY                    SE DECISION MADE: 08-OCT-04
WESTLAKE VILLAGE, CA 91362        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COULTER A T 5DIFF CAP PIERCE (CP)
BECKMAN COULTER, INC.             510(k) NO: K042173(ABBREVIATED)
ATTN: LOURDES  COBA               PHONE NO : 305-380-4079
11800 SW 147TH AVE.               SE DECISION MADE: 12-OCT-04
MIAMI, FL 33196-2500              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
BECKMAN COULTER, INC.             510(k) NO: K042651(TRADITIONAL)
ATTN: VALYNDA  MACHEN             PHONE NO : 952-368-1383
1000 LAKE HAZELTINE DR.           SE DECISION MADE: 05-OCT-04
CHASKA, MN 55318-1084             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER
BECKMAN COULTER, INC.             510(k) NO: K042724(SPECIAL)
ATTN: STAN  SUGRUE                PHONE NO : 305-380-4552
11800 S.W. 147TH AVE.             SE DECISION MADE: 29-OCT-04
MAIL CODE 31-B06                  510(k) SUMMARY AVAILABLE FROM FDA
MIAMI, FL 33196-2500

 
DEVICE: BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE M
BECTON DICKINSON                  510(k) NO: K041478(TRADITIONAL)
ATTN: JOHN  SCHALAGO              PHONE NO : 201-847-5663
1 BECTON DR.                      SE DECISION MADE: 28-OCT-04
FRANKLIN LAKES, NJ 07417-1880     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 1BD SOLOSHOT IX SYRINGE
BECTON DICKINSON & CO.            510(k) NO: K042934(SPECIAL)
ATTN: PETER  ZURLO                PHONE NO : 201-847-6447
1 BECTON DRIVE                    SE DECISION MADE: 28-OCT-04
FRANKLIN LAKES, NJ 07417          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTIMA MX
BIEN-AIR SA SWITZERLAND           510(k) NO: K042759(TRADITIONAL)
ATTN: ALAIN  LEONETTI             PHONE NO : +41 323 446464
LANGASSE 60, CASE POSTALE         SE DECISION MADE: 20-OCT-04
BIENNE 6, SWITZERLAND CH-2500     510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE T
BIO-LOK INTL., INC.               510(k) NO: K041136(TRADITIONAL)
ATTN: ELAINE  DUNCAN              PHONE NO : 715-549-6035
P.O. BOX 560                      SE DECISION MADE: 22-OCT-04
STILLWATER, MN 55082              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAXAIR SURGICAL HELMET SYSTEM
BIO-MEDICAL DEVICES, INC.         510(k) NO: K040485(TRADITIONAL)
ATTN: NICK  HERBERT               PHONE NO : 949-752-9642
17171 DAIMLER AVE.                SE DECISION MADE: 18-OCT-04
IRVINE, CA 92614                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5
BIO-RAD                           510(k) NO: K042324(TRADITIONAL)
ATTN: MARIA  ZEBELLOS             PHONE NO : 949-598-1200
9500 JERONIMO RD.                 SE DECISION MADE: 07-OCT-04
IRVINE, CA 92618-2017             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL M
BIO-RAD LABORATORIES, INC.        510(k) NO: K042336(TRADITIONAL)
ATTN: MARIA  ZEBALLOS             PHONE NO : 949-598-1367
9500 JERONIMO RD.                 SE DECISION MADE: 14-OCT-04
IRVINE, CA 92618-2017             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIQUI-HEME GLYCO A1C ASSAY
BIODIAGNOSTIC INTL                510(k) NO: K031296(TRADITIONAL)
ATTN: PAUL  ANAND                 PHONE NO : 714-529-7797
615 NORTH BERRY ST.               SE DECISION MADE: 15-OCT-04
# E                               510(k) STATEMENT
BREA, CA 92821

DEVICE: BIOMEDIX PADNET LAB
BIOMEDIX, INC.                    510(k) NO: K042616(TRADITIONAL)
ATTN: WILLIAM  ROGERS             PHONE NO : 651-762-4010
4205 WHITE BEAR PKWY.             SE DECISION MADE: 12-OCT-04
ST. PAUL, MN 55110                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

 
DEVICE: ARTHROTEK MENISCAL HYBRID DEVICE
BIOMET, INC.                      510(k) NO: K041988(TRADITIONAL)
ATTN: GARY  BAKER                 PHONE NO : 574-267-6639
56 EAST BELL DR.                  SE DECISION MADE: 20-OCT-04
PO BOX 587                        510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587

DEVICE: MAESTRO TOTAL WRIST
BIOMET, INC.                      510(k) NO: K042032(TRADITIONAL)
ATTN: PATRICIA  SANDBORN BERES    PHONE NO : 574-267-6639
56 EAST BELL DR. P.O. BOX 587     SE DECISION MADE: 07-OCT-04
WARSAW, IN 46581-0587             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: M2A MAGNUM SYSTEM
BIOMET, INC.                      510(k) NO: K042037(TRADITIONAL)
ATTN: KACY  ARNOLD                PHONE NO : 574-267-6639
56 EAST BELL DR. P.O. BOX 587     SE DECISION MADE: 01-OCT-04
WARSAW, IN 46581-0587             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QC-BEADS
BIOSCREEN INC.                    510(k) NO: K042750(TRADITIONAL)
ATTN: ALICE  DEUTSCH              PHONE NO : 212-260-6692
889 BROADWAY - SUITE 6A           SE DECISION MADE: 29-OCT-04
NEW YORK, NY 10003                510(k) STATEMENT

DEVICE: ERA 3000 PACING SYSTEM ANALYZER
BIOTRONIK, INC.                   510(k) NO: K042708(SPECIAL)
ATTN: JON  BRUMBAUGH              PHONE NO : 888-345-0374
6024 JEAN RD.                     SE DECISION MADE: 20-OCT-04
LAKE OSWEGO, OR 97035             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM
BLACKSTONE MEDICAL, INC.          510(k) NO: K042514(SPECIAL)
ATTN: DEAN E CIPORKIN             PHONE NO : 413-731-8711
90 BROOKSDALE DR.                 SE DECISION MADE: 07-OCT-04
SPRINGFIELD, MA 01104             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000
BLEASE MEDICAL EQUIPMENT LTD.     510(k) NO: K041430(SPECIAL)
ATTN: ARTHUR J WARD               PHONE NO : 813-645-2855
962 ALLEGRO LN.                   SE DECISION MADE: 07-OCT-04
APOLLO BEACH, FL 33572            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-1
BOSTON SCIENTIFIC CORP.           510(k) NO: K042539(SPECIAL)
ATTN: JAMES  LEATHLEY             PHONE NO : 510-440-7836
47900 BAYSIDE PARKWAY             SE DECISION MADE: 19-OCT-04
FREMONT, CA 94538-6515            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXCELSIOR 1018 AND SL-10 MICROCATHETERS
BOSTON SCIENTIFIC CORP.           510(k) NO: K042568(SPECIAL)
ATTN: VICTOR  HAM                 PHONE NO : 510-440-7604
47900 BAYSIDE PARKWAY             SE DECISION MADE: 15-OCT-04
FREMONT, CA 94538-6515            510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER
BRAEMAR, INC.                     510(k) NO: K042469(TRADITIONAL)
ATTN: DARREN  DERSHEM             PHONE NO : 952-890-5135
11481 RUPP DR.                    SE DECISION MADE: 06-OCT-04
BURNSVILLE, MN 55337              510(k) STATEMENT

DEVICE: VECTORVISION UNI-KNEE
BRAINLAB AG                       510(k) NO: K041899(SPECIAL)
ATTN: RAINER  BIRKENBACH          PHONE NO : 49 89 9915680
AMMERTHALSTRASSE 8                SE DECISION MADE: 06-OCT-04
HEIMSTETTEN, GERMANY 85551        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KOLIBRI IMAGE GUIDED SURGERY SYSTEM
BRAINLAB AG                       510(k) NO: K042391(TRADITIONAL)
ATTN: JENS  WITTE                 PHONE NO : 49 89 9915680
AMMERTHALSTRASSE 8                SE DECISION MADE: 19-OCT-04
HEIMSTETTEN, GERMANY 85551        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IPLAN!
BRAINLAB, AG                      510(k) NO: K041703(TRADITIONAL)
ATTN: RAINER  BIRKENBACH          PHONE NO : 498 999 15680
AMMERTHALSTRASSE 8                SE DECISION MADE: 22-OCT-04
HEIMSTETTEN, GERMANY 85551        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E-PAIN CARE
BREG, INC.                        510(k) NO: K041714(TRADITIONAL)
ATTN: KATHLEEN  BARBER            PHONE NO : 760-599-5719
2611 COMMERCE WAY                 SE DECISION MADE: 01-OCT-04
VISTA, CA 92083                   510(k) STATEMENT

DEVICE: C-BOOT
C-BOOT LTD.                       510(k) NO: K041659(TRADITIONAL)
ATTN: AVI  ABRAHAM                PHONE NO : 972 544 949699
8 MARVA STREET                    SE DECISION MADE: 28-OCT-04
CARMIEL, ISRAEL 21691             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDEON COBRA CATHETER
CARDEON CORP.                     510(k) NO: K042156(TRADITIONAL)
ATTN: JANE  BEGGS                 PHONE NO : 408-517-2522
10600 NORTH TANTAU AVE.           SE DECISION MADE: 06-OCT-04
CUPERTINO, CA 95014               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VASOSTASIS VASCULAR CLOSURE SYSTEM
CARDIVA MEDICAL, INC.             510(k) NO: K041486(TRADITIONAL)
ATTN: AUGUSTINE  LIEN             PHONE NO : 650-964-8900
2585 LEGHORN ST.                  SE DECISION MADE: 22-OCT-04
MOUNTAIN VIEW, CA 94043           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOO
CENTERPULSE ORTHOPEDICS, INC.     510(k) NO: K033943(TRADITIONAL)
ATTN: AUDREY  SWEARINGEN          PHONE NO : 512-432-9255
9900 SPECTRUM DR.                 SE DECISION MADE: 18-OCT-04
AUSTIN, TX 78717                  510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: KARATS MULTIPURPOSE SOLUTION
CIBA VISION CORPORATION           510(k) NO: K031753(TRADITIONAL)
ATTN: STEVEN  DOWDLEY             PHONE NO : 678-415-3897
11460 JOHNS CREEK PKWY.           SE DECISION MADE: 28-OCT-04
DULUTH, GA 30097                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIO-CHEM ANALYZER, MODEL 100
CLINICAL ANALYSIS CORPORATION, INC510(k) NO: K040750(TRADITIONAL)
ATTN: CHARLES  MCBRAIRTY          PHONE NO : 215-536-1137
2100 QUAKER POINTE DRIVE          SE DECISION MADE: 28-OCT-04
QUAKERTOWN, PA 18951-2182         510(k) STATEMENT

DEVICE: PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606
CLINICO                           510(k) NO: K041919(ABBREVIATED)
ATTN: REINHARD  HOPF              PHONE NO : 011 49 6621168480
5 ROBERT-KOCH-STRASSE             SE DECISION MADE: 04-OCT-04
BAD HERSFELD, GERMANY D-36251     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CDX DIGITAL X-RAY IMAGING SYSTEM
CNC IMAGING, INC.                 510(k) NO: K042736(TRADITIONAL)
ATTN: KORINA A AKHONDZADEH        PHONE NO : 760-798-9642
1559 EDEN COURT                   SE DECISION MADE: 13-OCT-04
SAN ELIJO HILLS, CA 92078         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXAM-PACS
COACTIV, LLC                      510(k) NO: K042647(TRADITIONAL)
ATTN: CARL  ALLETTO               PHONE NO : 940-300-8601
1100 LAKEVIEW BLVD                SE DECISION MADE: 07-OCT-04
DENTON, TX 76208                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: IV ADMINISTRATION SET B400 SP
CODAN US CORP.                    510(k) NO: K042693(TRADITIONAL)
ATTN: ROHIT  PATEL                PHONE NO : 714-545-2111
3511 WEST SUNFLOWER AVE.          SE DECISION MADE: 21-OCT-04
SANTA ANA, CA 92704-6944          510(k) STATEMENT

DEVICE: NP-2600 SERIES HARDCOPY PRINTERS
CODONICS, INC.                    510(k) NO: K042232(TRADITIONAL)
ATTN: ALAN  DESANTIS              PHONE NO : 440-243-1198
17991 ENGLEWOOD DR.               SE DECISION MADE: 05-OCT-04
MIDDLEBURG HEIGHTS, OH 44130      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MENTAMOVE
COLE & ASSOCIATES                 510(k) NO: K040849(TRADITIONAL)
ATTN: RICHARD O WOOD              PHONE NO : 312-807-4364
70 W. MADISON ST.                 SE DECISION MADE: 01-OCT-04
SUITE 3300                        510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60602

DEVICE: INTRAUTERINE VENOGRAM NEEDLE SET
COOK UROLOGICAL, INC.             510(k) NO: K041062(TRADITIONAL)
ATTN: CINDY  RUMPLE               PHONE NO : 812-829-6500
1100 WEST MORGAN ST.              SE DECISION MADE: 01-OCT-04
SPENCER, IN 47460                 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: ZILVER 518 BILIARY STENT
COOK, INC.                        510(k) NO: K042518(SPECIAL)
ATTN: LELAND  KEYT                PHONE NO : 800-346-2686
750 DANIELS WAY PO BX 489         SE DECISION MADE: 01-OCT-04
BLOOMINGTON, IN 47402             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COOPER PROSTHETIC
COOPERVISION, INC.                510(k) NO: K042435(TRADITIONAL)
ATTN: BONNIE J TSMBAL             PHONE NO : 585-264-3210
711 NORTH RD.                     SE DECISION MADE: 26-OCT-04
SCOTTSVILLE, NY 14546             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
CRYOVASCULAR SYSTEMS, INC.        510(k) NO: K042541(SPECIAL)
ATTN: KIM  TOMPKINS               PHONE NO : 408-866-3203
160 KNOWLES DR.                   SE DECISION MADE: 12-OCT-04
LOS GATOS, CA 95032               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LSO PET/CT HIREZ 64
CTI PET SYSTEMS, INC.             510(k) NO: K042467(SPECIAL)
ATTN: M. ALAINE  MEDIO            PHONE NO : 865-218-2703
810 INNOVATION DR.                SE DECISION MADE: 01-OCT-04
KNOXVILLE, TN 37932-2571          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM
CURELIGHT LTD                     510(k) NO: K041994(TRADITIONAL)
ATTN: JONATHAN S KAHN             PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W.       SE DECISION MADE: 06-OCT-04
WASHINGTON, DC 20004-1109         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CUTERA TABLETOP AESTHETIC PRODUCT
CUTERA, INC.                      510(k) NO: K042165(TRADITIONAL)
ATTN: KATHY  MAYNOR               PHONE NO : 415-657-5586
3240 BAYSHORE BLVD.               SE DECISION MADE: 18-OCT-04
BRISBANE, CA 94005                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: 3 SERIES PHOTOTHERAPY CABINET
DAAVLIN DISTRIBUTING CO.          510(k) NO: K042502(TRADITIONAL)
ATTN: DAVID W SWANSON             PHONE NO : 419-636-6304
205 WEST BEMENT ST.               SE DECISION MADE: 14-OCT-04
BRYAN, OH 43506                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONTROL PLASMA N AND CONTROL PLASMA P
DADE BEHRING, INC.                510(k) NO: K042209(TRADITIONAL)
ATTN: DONNA A WOLF                PHONE NO : 302-631-0384
514 GBC DR.                       SE DECISION MADE: 21-OCT-04
NEWARK, DE 19702                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMIT CAFFEINE ASSAY
DADE BEHRING, INC.                510(k) NO: K042407(TRADITIONAL)
ATTN: YUK-TING  LEWIS             PHONE NO : 302-631-7626
P.O. BOX 6101                     SE DECISION MADE: 28-OCT-04
M/S 514                           510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101

 
DEVICE: GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3
DATEX-OHMEDA                      510(k) NO: K042771(SPECIAL)
ATTN: JOEL  KENT                  PHONE NO : 781-449-8685
86 PILGRIM RD.                    SE DECISION MADE: 15-OCT-04
NEEDHAM, MA 02492                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GE DATEX-OHMEDA ENGSTROM CARESTATION
DATEX-OHMEDA, INC.                510(k) NO: K041775(TRADITIONAL)
ATTN: DAN  KOSEDNAR               PHONE NO : 608-221-1551
PO BOX 7550                       SE DECISION MADE: 26-OCT-04
MADISON, WI 53707                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GELATO PROPHYLAXIS PASTE
DEEPAK PRODUCTS, INC.             510(k) NO: K042048(TRADITIONAL)
ATTN: RICARDO A CARLES            PHONE NO : 305-805-2216
5220 NW 72ND AVE., BAY #15        SE DECISION MADE: 26-OCT-04
MIAMI, FL 33166                   510(k) STATEMENT

DEVICE: HDL-EX SEIKEN ASSAY KIT
DENKA SEIKEN CO., LTD.            510(k) NO: K041090(TRADITIONAL)
ATTN: TOSHIMI  MATSUNAGA          PHONE NO : 812 504 27221
1-2-2, MINAMIHONCHO,              SE DECISION MADE: 29-OCT-04
GOSEN CITY                        510(k) SUMMARY AVAILABLE FROM FDA
NIIGATA, JAPAN 959-1695

DEVICE: DYRACT CEM PLUS CEMENT
DENTSPLY INTL.                    510(k) NO: K041272(TRADITIONAL)
ATTN: P. JEFFERY  LEHN            PHONE NO : 717-845-7511
221 WEST PHILADELPHIA STREET      SE DECISION MADE: 18-OCT-04
SUITE 60                          510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404

DEVICE: DORSAL INTRAMEDULLARY PLATE
DEO VOLENTE ORTHOPAEDICS, LLC     510(k) NO: K042437(TRADITIONAL)
ATTN: DINA L WEISSMAN, J.D.       PHONE NO : 574-267-8828
P.O. BOX 83                       SE DECISION MADE: 08-OCT-04
WARSAW, IN 46581                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMARTMIX PRE-FILLED MIXING SYSTEM
DEPUY ORTHOPAEDICS, INC.          510(k) NO: K042591(SPECIAL)
ATTN: TIFFANI  ROGERS             PHONE NO : 574-371-4927
700 ORTHOPAEDIC DR.               SE DECISION MADE: 22-OCT-04
P.O. BOX 988                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988

DEVICE: SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM
DEPUY SPINE, INC.                 510(k) NO: K042508(SPECIAL)
ATTN: SHARON  STAROWICZ           PHONE NO : 508-828-2867
325 PARAMOUNT DR.                 SE DECISION MADE: 07-OCT-04
RAYNHAM, MA 02767                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROALBUMIN MULTI-CALIBRATOR SET
DIAGNOSTIC CHEMICALS LTD.         510(k) NO: K042243(TRADITIONAL)
ATTN: NANCY  OLSCAMP              PHONE NO : 902 566 1396
16 MCCARVILLE ST.                 SE DECISION MADE: 04-OCT-04
WEST ROYALTY INDUSTRIAL PARK      510(k) STATEMENT
CHARLOTTETOWN, PRINCE EDWARD, CANADA C1E 2A6

 
DEVICE: AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM
DIAMOND AGE SYSTEMS, INC.         510(k) NO: K042439(TRADITIONAL)
ATTN: GEOFFREY D SWANK            PHONE NO : 303-263-3307
3775 SOUTH LAUREL WAY             SE DECISION MADE: 07-OCT-04
CHANDLER, AZ 85249                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DIAZYME SODIUM ENZYMATIC ASSAY
DIAZYME LABORATORIES              510(k) NO: K042189(TRADITIONAL)
ATTN: HUHAN  TRAN                 PHONE NO : 858-455-4761
3550 GENERAL ATOMICS CT.          SE DECISION MADE: 07-OCT-04
SAN DIEGO, CA 92121               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAZYME POTASSIUM ENZYMATIC ASSAY KIT
DIAZYME LABORATORIES              510(k) NO: K042191(TRADITIONAL)
ATTN: HUAN  TRAN                  PHONE NO : 858-455-4761
3550 GENERAL ATOMICS CT.          SE DECISION MADE: 29-OCT-04
SAN DIEGO, CA 92121               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT
DIAZYME LABORATORIES              510(k) NO: K042193(TRADITIONAL)
ATTN: CHONG  YUAN                 PHONE NO : 858-455-4761
3550 GENERAL ATOMICS CT.          SE DECISION MADE: 29-OCT-04
SAN DIEGO, CA 92121               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DRG SOFTRELEASE
DOCTOR'S RESEARCH GROUP, INC.     510(k) NO: K041018(TRADITIONAL)
ATTN: EDWARD H GOLDMAN            PHONE NO : 860-283-1479
50 ALTAIR AVE.                    SE DECISION MADE: 18-OCT-04
PLYMOUTH, CT 06782                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5
DRAEGER MEDICAL SYSTEMS, INC.     510(k) NO: K042656(SPECIAL)
ATTN: PENELOPE H GRECO            PHONE NO : 978-907-7500
16 ELECTRONICS AVE.               SE DECISION MADE: 06-OCT-04
DANVERS, MA 01923                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM
DRAEGER MEDICAL, INC.             510(k) NO: K042419(TRADITIONAL)
ATTN: MICHAEL A KELHART           PHONE NO : 215-721-5400
3135 QUARRY RD.                   SE DECISION MADE: 08-OCT-04
TELFORD, PA 18969                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CYBIRD LED CURING LIGHT
DXM CO., LTD.                     510(k) NO: K042703(TRADITIONAL)
ATTN: CAROLANN  KOTULA            PHONE NO : 770-985-8203
55 NORTHERN BLVD.                 SE DECISION MADE: 12-OCT-04
SUITE 200                         510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021              THIRD PARTY REVIEW

DEVICE: EBI CAS SPINE SPACER SYSTEM
EBI, L.P.                         510(k) NO: K042268(SPECIAL)
ATTN: FREDERIC  TESTA             PHONE NO : 973-299-9300
100 INTERPACE PKWY.               SE DECISION MADE: 27-OCT-04
PARSIPPANY, NJ 07054              510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: IQQA-CHEST SOFTWARE PACKAGE
EDDA TECHNOLOGY, INC.             510(k) NO: K042408(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 847-374-1727
P.O. BOX 7007                     SE DECISION MADE: 08-OCT-04
DEERFIELD, IL 60015               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER
ELA MEDICAL INC                   510(k) NO: K042002(TRADITIONAL)
ATTN: SUSAN  OLIVE                PHONE NO : 763-519-9400
2950 XENIUM LN. N. STE. 120       SE DECISION MADE: 20-OCT-04
PLYMOUTH, MN 55441                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LASEREX, MODEL LP4532
ELLEX MEDICAL PTY. LTD.           510(k) NO: K041598(TRADITIONAL)
ATTN: KEVIN  HOWARD               PHONE NO : 618 810 45200
74 TO 86 GILBERT ST.              SE DECISION MADE: 06-OCT-04
ADELAIDE, SOUTH AUSTRALIA, AUSTRAL510(k) STATEMENT

DEVICE: ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
ENDIUS, INC.                      510(k) NO: K041808(SPECIAL)
ATTN: CHRISTINE  KUNTZ-NASSIF     PHONE NO : 508-643-0983
23 WEST BACON ST.                 SE DECISION MADE: 01-OCT-04
PLAINVILLE, MA 02762              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENSITE SYSTEM, MODEL EE3000
ENDOCARDIAL SOLUTIONS, INC.       510(k) NO: K042493(SPECIAL)
ATTN: KAREN J MCKELVEY            PHONE NO : 651-632-9454
1350 ENERGY LN., SUITE 110        SE DECISION MADE: 15-OCT-04
ST. PAUL, MN 55108                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS
ERBE USA, INC.                    510(k) NO: K033421(ABBREVIATED)
ATTN: JULIE  STEPHENS             PHONE NO : 678-513-0693
111 LAUREL RIDGE DRIVE            SE DECISION MADE: 14-OCT-04
ALPHARETTA, GA 30004              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: G-SCAN
ESAOTE, S.P.A.                    510(k) NO: K042236(TRADITIONAL)
ATTN: CARRI  GRAHAM               PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE              SE DECISION MADE: 04-OCT-04
INDIANAPOLIS, IN 46250            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLUCOSE TOLERANCE BEVERAGE
EVER SCIENTIFIC                   510(k) NO: K042183(TRADITIONAL)
ATTN: JAY  REINHARDT              PHONE NO : 610-209-1343
7 WETHERILL LANE                  SE DECISION MADE: 27-OCT-04
CHESTER SPRINGS, PA 19425         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS
EXACTECH, INC.                    510(k) NO: K040601(ABBREVIATED)
ATTN: GARY  MILLER                PHONE NO : 352-377-1140
2320 N.W. 66TH CT.                SE DECISION MADE: 04-OCT-04
GAINESVILLE, FL 32653             510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: EXACTECH OPTETRAK UNICONDYLAR KNEE
EXACTECH, INC.                    510(k) NO: K040889(TRADITIONAL)
ATTN: GARY  MILLER                PHONE NO : 352-377-1140
2320 N.W. 66TH CT.                SE DECISION MADE: 01-OCT-04
GAINESVILLE, FL 32653             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXACTECH EQUINOXE SHOULDER SYSTEM
EXACTECH, INC.                    510(k) NO: K042021(TRADITIONAL)
ATTN: GARY  MILLER                PHONE NO : 352-377-1140
2320 N.W. 66TH CT.                SE DECISION MADE: 26-OCT-04
GAINESVILLE, FL 32653             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BALANCEBACK VNG SYSTEM
FALL PREVENTION TECHNOLOGIES, LLC 510(k) NO: K042529(TRADITIONAL)
ATTN: KEITH  KRAVITZ              PHONE NO : 561-995-8883
2300 NW CORPORATE BLVD.           SE DECISION MADE: 06-OCT-04
SUITE 141                         510(k) SUMMARY AVAILABLE FROM FDA
BOCA RATON, FL 33431              THIRD PARTY REVIEW

DEVICE: MAMMOTEST
FISCHER IMAGING CORP.             510(k) NO: K042095(TRADITIONAL)
ATTN: ROBERT G SCHUEPPERT         PHONE NO : 303-254-2525
12300 NORTH GRANT ST.             SE DECISION MADE: 29-OCT-04
DENVER, CO 80241-3120             510(k) STATEMENT

DEVICE: TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
FMD, LLC                          510(k) NO: K042561(SPECIAL)
ATTN: YOUSRY  FARAGALLA           PHONE NO : 703-880-4642
P.O. BOX 1500                     SE DECISION MADE: 12-OCT-04
LORTON, VA 22199-1500             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TITANIUM TELEGRAPH HUMERAL NAIL
FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K042332(TRADITIONAL)
ATTN: CHRISTINE  QUENDEZ          PHONE NO : 332 985 56895
ZI DE KERNEVEZ-6 RUE NOBEL        SE DECISION MADE: 07-OCT-04
QUIMPER, FRANCE 29000             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRIADENT PLUS DENTAL IMPLANT SYSTEMS
FRIADENT GMBH                     510(k) NO: K040170(TRADITIONAL)
ATTN: CAROL  PATTERSON            PHONE NO : 949-462-0900
21911 ERIE LN.                    SE DECISION MADE: 27-OCT-04
LAKE FOREST, CA 92630             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRC
GALIL MEDICAL LTD.                510(k) NO: K042667(SPECIAL)
ATTN: JONATHAN S KAHN             PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W.       SE DECISION MADE: 14-OCT-04
WASHINGTON, DC 20009              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS
GAMBRO RENAL PRODUCTS             510(k) NO: K041005(ABBREVIATED)
ATTN: THOMAS B DOWELL             PHONE NO : 303-231-4094
10810 WEST COLLINS AVE.           SE DECISION MADE: 07-OCT-04
LAKEWOOD, CO 80215                510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: MI PASTE
GC AMERICA, INC.                  510(k) NO: K042200(TRADITIONAL)
ATTN: TERRY L JORITZ              PHONE NO : 708-926-3105
3737 WEST 127TH ST.               SE DECISION MADE: 20-OCT-04
ALSIP, IL 60803                   510(k) STATEMENT

DEVICE: CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICI
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K042525(TRADITIONAL)
ATTN: CAROL  ALLOIAN              PHONE NO : 847-704-3060
800 BUSINESS CENTER DR.           SE DECISION MADE: 01-OCT-04
MOUNT PROSPECT, IL 60056          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT
GENERAL ATOMICS                   510(k) NO: K042448(TRADITIONAL)
ATTN: HUAN  TRAN                  PHONE NO : 858-455-4761
3550 GENERAL ATOMICS COURT        SE DECISION MADE: 29-OCT-04
SAN DIEGO, CA 92121               510(k) STATEMENT

DEVICE: GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE
GIVEN IMAGING LTD.                510(k) NO: K041149(TRADITIONAL)
ATTN: SHOSH  FRIEDMAN             PHONE NO : 011 972 49097784
13 HAYETZIRA STREET               SE DECISION MADE: 25-OCT-04
NEW INDUSTRIAL ZONE               510(k) SUMMARY AVAILABLE FROM FDA
YOKNEAM, ISRAEL 20692

DEVICE: KELES FACEMASK
GREAT LAKES ORTHODONTICS, LTD.    510(k) NO: K041718(TRADITIONAL)
ATTN: DAVE  GRAVER                PHONE NO : 800-828-7626
200 COOPER AVE.                   SE DECISION MADE: 15-OCT-04
P.O. BOX 5111                     510(k) SUMMARY AVAILABLE FROM FDA
TONAWANDA, NY 14151-5111

DEVICE: BITECH BIPOLAR SCISSORS
GUENTER BISSINGER MEDIZINTECHNIK G510(k) NO: K042077(TRADITIONAL)
ATTN: FRANZ  MENEAN               PHONE NO : 49 746 399540
47 GRIESWEG                       SE DECISION MADE: 27-OCT-04
MUEHLHEIM, BADEN-WUERTTEMBERG, GER510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GYRUS PLASMACISION LAPAROSCOPIC SPATULA
GYRUS MEDICAL, INC.               510(k) NO: K041633(TRADITIONAL)
ATTN: DAVID E CHADWICK            PHONE NO : 763-416-7239
6655 WEDGWOOD ROAD, SUITE 160     SE DECISION MADE: 22-OCT-04
MAPLE GROVE, MN 55311-3602        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GALILEO GOLD
HAMILTON MEDICAL, INC.            510(k) NO: K040574(TRADITIONAL)
ATTN: J. DAVID  THOMPSON          PHONE NO : 775-858-3200
P.O. BOX 30008                    SE DECISION MADE: 27-OCT-04
RENO, NV 89520                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168
HEALTH & LIFE CO., LTD.           510(k) NO: K042802(SPECIAL)
ATTN: PAUL  HUNG                  PHONE NO : 886 2 82271300
9F, NO.186, JIAN YI ROAD          SE DECISION MADE: 26-OCT-04
CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT

 
DEVICE: ACU-STRAP MOTION SICKNESS BAND
HEALTH ENT., INC.                 510(k) NO: K041877(TRADITIONAL)
ATTN: DANIEL J DILLON             PHONE NO : 508-643-0434
49 PLAIN STREET                   SE DECISION MADE: 08-OCT-04
NORTH ATTLEBORO, MA 02760         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II /
HEIDELBERG ENGINEERING            510(k) NO: K042742(TRADITIONAL)
ATTN: GERHARD  ZINSER             PHONE NO : +49 622 164630
GERHART-HAUPTMANN-STRASSE 30      SE DECISION MADE: 13-OCT-04
69221 DOSSENHEIM, GERMANY         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6
HEINZ KURZ GMBH MEDIZINTECHNIK    510(k) NO: K042503(TRADITIONAL)
ATTN: DAGMAR  MASER               PHONE NO : 31 20 4289591
AMSTEL 320-I                      SE DECISION MADE: 01-OCT-04
AMSTERDAM, NETHERLANDS 1017 AP    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ETG-4000 OPTICAL TOPOGRAPHY SYSTEM
HITACHI MEDICAL CORP.             510(k) NO: K042501(SPECIAL)
ATTN: DOUG  THISTLEWAITE          PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK         SE DECISION MADE: 12-OCT-04
TWINSBURG, OH 44087               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS
HOLOGIC, INC.                     510(k) NO: K042480(TRADITIONAL)
ATTN: DANIEL F PHELAN             PHONE NO : 781-999-7538
35 CROSBY DR.                     SE DECISION MADE: 29-OCT-04
BEDFORD, MA 01730                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
HOSPIRA, INC.                     510(k) NO: K042609(TRADITIONAL)
ATTN: RAY  SILKAITIS              PHONE NO : 224-212-4897
275 N. FIELD DRIVE                SE DECISION MADE: 06-OCT-04
LAKE FOREST, IL 60045-5045        510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
HOSPIRA, INC.                     510(k) NO: K042800(TRADITIONAL)
ATTN: THOMAS  KOZMA               PHONE NO : 224-212-4803
275 N. FIELD DR., BLDG. H-2       SE DECISION MADE: 18-OCT-04
D-389                             510(k) SUMMARY AVAILABLE FROM FDA
LAKE FOREST, IL 60045-5045        THIRD PARTY REVIEW

DEVICE: HOVEROUND MPV-5 POWERCHAIR
HOVEROUND CORP.                   510(k) NO: K042545(TRADITIONAL)
ATTN: TONY  DIGIOVANNI            PHONE NO : 941-739-6200
2151 WHITFIELD INDUSTRIAL WAY     SE DECISION MADE: 21-OCT-04
SARASOTA, FL 34243                510(k) STATEMENT

DEVICE: T2 PROXIMAL HUMERAL NAIL
HOWMEDICA OSTEONICS CORP.         510(k) NO: K042396(TRADITIONAL)
ATTN: VIVIAN  KELLY               PHONE NO : 201-831-5581
325 CORPORATE DRIVE               SE DECISION MADE: 08-OCT-04
MAHWAH, NJ 07430                  510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: IMPLANTMASTER
I-DENT                            510(k) NO: K042212(TRADITIONAL)
ATTN: DAN  LAOR                   PHONE NO : 972 545 311547
4 YOHANAN STREET, BOX 6402        SE DECISION MADE: 21-OCT-04
HOD HASHARON, ISRAEL 45241        510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: NAVIGUS PASSIVE PROBE, MODEL NP-1000
IMAGE-GUIDED NEUROLOGICS, INC.    510(k) NO: K040334(TRADITIONAL)
ATTN: DAVID M LEE                 PHONE NO : 321-309-8237
2290 EAU GALLIE BLVD.             SE DECISION MADE: 04-OCT-04
MELBOURNE, FL 32935               510(k) STATEMENT

DEVICE: IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA
IMMCO DIAGNOSTICS, INC.           510(k) NO: K041102(TRADITIONAL)
ATTN: KEVIN J LAWSON              PHONE NO : 716-691-0091
60 PINEVIEW DR.                   SE DECISION MADE: 26-OCT-04
BUFFALO, NY 14228-2120            510(k) STATEMENT

DEVICE: IDI-MRSA ASSAY
INFECTIO DIAGNOSTIC (I.D.I.) INC. 510(k) NO: K042357(SPECIAL)
ATTN: JUDITH  SMITH               PHONE NO : 410-592-2060
13801 ECK ROAD                    SE DECISION MADE: 22-OCT-04
HYDES, MD 21082                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXCELLA-M SPINAL SYSTEM
INNOVASIS, INC.                   510(k) NO: K042143(TRADITIONAL)
ATTN: BRENT A FELIX               PHONE NO : 801-557-1445
997 EAST 3900 SOUTH               SE DECISION MADE: 07-OCT-04
SUITE 103                         510(k) SUMMARY AVAILABLE FROM FDA
SALT LAKE CITY, UT 84124

DEVICE: EQUI-FLOW VALVE AND SHUNT SYSTEM
INTEGRA NEUROSCIENCES IMPLANTS S.A510(k) NO: K042558(TRADITIONAL)
ATTN: JUDITH  O'GRADY             PHONE NO : 609-936-2311
311 ENTERPRISE DRIVE              SE DECISION MADE: 06-OCT-04
PLAINSBORO, NJ 08536              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRATED PATIENT MONITORING SYSTEM
INVIVO RESEARCH, INC.             510(k) NO: K041918(TRADITIONAL)
ATTN: NEIL  BATTISTE              PHONE NO : 800-331-3220
12601 RESEARCH PKWY.              SE DECISION MADE: 15-OCT-04
ORLANDO, FL 32826                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 60
ISOPURE CORP.                     510(k) NO: K041163(TRADITIONAL)
ATTN: KEVIN  GILLESPIE            PHONE NO :
129 CITIZENS BLVD.                SE DECISION MADE: 07-OCT-04
SIMPSONVILLE, KY 40067            510(k) STATEMENT

DEVICE: OSSATURA DENTAL
ISOTIS ORTHOBIOLOGICS, INC        510(k) NO: K042706(TRADITIONAL)
ATTN: PAUL  DONER                 PHONE NO : 949-855-7168
2 GOODYEAR, SUITE B               SE DECISION MADE: 20-OCT-04
IRVINE, CA 92618                  510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: CROMAX HIGH SPEED TURBINE HANDPIECE
J.R. MEDICAL TECHNOLOGIES, INC.   510(k) NO: K041755(TRADITIONAL)
ATTN: J. HARVEY  KNAUSS           PHONE NO : 832-285-9423
11874 SOUTH EVELYN CIRCLE         SE DECISION MADE: 22-OCT-04
HOUSTON, TX 77071                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLLAGEN-ORC ANTIMICROBIAL MATRIX
JOHNSON & JOHNSON MEDICAL, LTD.   510(k) NO: K033523(TRADITIONAL)
ATTN: JOHN D PAULSON              PHONE NO : 908-218-2887
ROUTE 22 WEST                     SE DECISION MADE: 21-OCT-04
P.O. BOX 151                      510(k) SUMMARY AVAILABLE FROM FDA
SOMERVILLE, NJ 08876

DEVICE: FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM
JRI MANUFACTURING LTD             510(k) NO: K041353(TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 410-451-0639
P.O. BOX 4341                     SE DECISION MADE: 08-OCT-04
CROFTON, MD 21114                 510(k) STATEMENT

DEVICE: SCB/VALLEYLAB FORCE FX INTERFACE UNIT
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K041912(TRADITIONAL)
ATTN: SUSIE S CHEN                PHONE NO : 310-348-4201
600 CORPORATE POINTE DRIVE        SE DECISION MADE: 25-OCT-04
CULVER CITY, CA 90230-7600        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL B
KLIMAMED TECHNOLOGIE MEDIZINGERATE510(k) NO: K031728(TRADITIONAL)
ATTN: JAY  MANSOUR                PHONE NO : 770-777-4146
1308 MORNINGSIDE PARK DR.         SE DECISION MADE: 12-OCT-04
ALPHARETTA, GA 30022              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KLS MARTIN DRILL-FREE MMF SCREW
KLS-MARTIN L.P.                   510(k) NO: K042573(TRADITIONAL)
ATTN: JENNIFER  DAMATO            PHONE NO : 904-641-7746
1239-1 ST. JOHN'S IND. PKWY.      SE DECISION MADE: 18-OCT-04
SOUTH                             510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246

DEVICE: STELLAR 404 MONITORING SYSTEM
LARSEN & TOUBRO LIMITED           510(k) NO: K042560(TRADITIONAL)
ATTN: HARRY  GUGNANI              PHONE NO : 847-303-3906
1821 WALDEN OFFICE SQUARE         SE DECISION MADE: 06-OCT-04
SUITE 400                         510(k) SUMMARY AVAILABLE FROM FDA
SCHAUMBURG, IL 60173              THIRD PARTY REVIEW

DEVICE: BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS
LINVATEC BIOMATERIALS, LTD.       510(k) NO: K042517(SPECIAL)
ATTN: TUIJA  ANNALA               PHONE NO : 358 3 3165600
HERMIANKATU 6-8L                  SE DECISION MADE: 08-OCT-04
TAMPERE, FINLAND                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 50
MAINE STANDARDS CO.               510(k) NO: K041975(TRADITIONAL)
ATTN: CHRISTINE  BEACH            PHONE NO : 207-892-1300
765 ROOSEVELT TRAIL               SE DECISION MADE: 15-OCT-04
WINDHAM, ME 04062-5365            510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: TRANSDERM IONTO SYSTEM, MK 2
MATTIOLI ENGINEERING CORP.        510(k) NO: K042590(TRADITIONAL)
ATTN: MELISSA  MAHALL             PHONE NO : 301-623-2500
11800 BALTIMORE AVENUE            SE DECISION MADE: 14-OCT-04
SUITE 105                         510(k) SUMMARY AVAILABLE FROM FDA
BELTSVILLE, MD 20705

DEVICE: COLON CAR 1.2
MEDICSIGHT                        510(k) NO: K042674(SPECIAL)
ATTN: CAROL  MACDONALD            PHONE NO : 440 207 5985351
46 BERKELEY SQUARE                SE DECISION MADE: 19-OCT-04
LONDON, UNITED KINGDOM W 1J 5AT   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RSA-CMS
MEDIS MEDICAL IMAGING SYSTEMS, B.V510(k) NO: K042383(TRADITIONAL)
ATTN: J.I.  HOLLANDER             PHONE NO : 31 71 5223244
SCHUTTERSVELD 9                   SE DECISION MADE: 20-OCT-04
LEIDEN, NETHERLANDS 2316 XG       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE FUGO BLADE FOR GLAUCOMA
MEDISURG LTD.                     510(k) NO: K041019(TRADITIONAL)
ATTN: RICHARD J FUGO              PHONE NO : 610-277-3937
100 WEST FORNANCE ST.             SE DECISION MADE: 08-OCT-04
THE FUGO BUILDING                 510(k) SUMMARY AVAILABLE FROM FDA
NORRISTOWN, PA 19401

DEVICE: MODIFICATION TO MEDLINE STRIDER MIDI 3
MEDLINE INDUSTRIES, INC.          510(k) NO: K042763(SPECIAL)
ATTN: ANDREA  HAFERKAMP           PHONE NO : 847-837-2759
ONE MEDLINE PLACE                 SE DECISION MADE: 07-OCT-04
MUNDELEIN, IL 60060               510(k) STATEMENT

DEVICE: MEDLINE STRIDER MIDI 4
MEDLINE INDUSTRIES, INC.          510(k) NO: K042764(SPECIAL)
ATTN: MARGARET  STEPHENS          PHONE NO : 847-949-2277
ONE MEDLINE PLACE                 SE DECISION MADE: 08-OCT-04
MUNDELEIN, IL 60060               510(k) STATEMENT

DEVICE: PS MEDICAL STRATA II VALVE
MEDTRONIC NEUROSURGERY            510(k) NO: K042465(SPECIAL)
ATTN: JEFFREY  HENDERSON          PHONE NO : 805-968-1546
125 CREMONA DR.                   SE DECISION MADE: 19-OCT-04
GOLETA, CA 93117                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERTEX RECONSTRUCTION SYSTEM
MEDTRONIC SOFAMOR DANEK           510(k) NO: K042498(SPECIAL)
ATTN: RICHARD  TREHARNE           PHONE NO : 901-396-3133
1800 PYRAMID PLACE                SE DECISION MADE: 07-OCT-04
MEMPHIS, TN 38132                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORION ANTERIOR CERVICAL PLATING SYSTEM
MEDTRONIC SOFAMOR DANEK           510(k) NO: K042499(SPECIAL)
ATTN: RICHARD  TREHARNE           PHONE NO : 901-396-3133
1800 PYRAMID PLACE                SE DECISION MADE: 07-OCT-04
MEMPHIS, TN 38132                 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
MEDTRONIC SOFAMOR DANEK           510(k) NO: K042524(SPECIAL)
ATTN: RICHARD  TREHARNE           PHONE NO : 901-396-3133
1800 PYRAMID PLACE                SE DECISION MADE: 08-OCT-04
MEMPHIS, TN 38132                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K042402(SPECIAL)
ATTN: RICHARD  TREHARNE           PHONE NO : 901-396-3133
1800 PYRAMID PL.                  SE DECISION MADE: 01-OCT-04
MEMPHIS, TN 38132                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO EQUATION FIXATION SYSTEM
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K042453(SPECIAL)
ATTN: RICHARD  TREHARNE           PHONE NO : 901-396-3133
1800 PYRAMID PL.                  SE DECISION MADE: 07-OCT-04
MEMPHIS, TN 38132                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20
MEDTRONIC, INC.                   510(k) NO: K042070(SPECIAL)
ATTN: DAWN  STENSTROM             PHONE NO : 763-391-9604
7611 NORTHLAND DR.                SE DECISION MADE: 01-OCT-04
MINNEAPOLIS, MN 55428             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEPARINASE HR ACT CONTROL, MODEL 550-12
MEDTRONIC, INC.                   510(k) NO: K042175(SPECIAL)
ATTN: DAWN  STENSTROM             PHONE NO : 763-391-9604
7611 NORTHLAND DR.                SE DECISION MADE: 18-OCT-04
MINNEAPOLIS, MN 55428             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PURPLE/BLACK HEPARIN ASSAY CONTROL
MEDTRONIC, INC.                   510(k) NO: K042206(SPECIAL)
ATTN: DAWN  STENSTROM             PHONE NO : 763-391-9604
7611 NORTHLAND DR.                SE DECISION MADE: 18-OCT-04
MINNEAPOLIS, MN 55428             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEGA PURE CART
MEGA SERVICES                     510(k) NO: K031832(TRADITIONAL)
ATTN: ROBERT  OLIVER              PHONE NO : 210-945-8448
106 LOST MEADOWS DRIVE            SE DECISION MADE: 20-OCT-04
CIBOLO, TX 78108                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MENTOR GENESIS PENILE PROSTHESIS
MENTOR CORP.                      510(k) NO: K040959(TRADITIONAL)
ATTN: DONNA A CRAWFORD            PHONE NO : 805-879-6304
201 MENTOR DR.                    SE DECISION MADE: 29-OCT-04
SANTA BARBARA, CA 93111           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65
MESURE TECHNOLOGY CO.,LTD.        510(k) NO: K042627(SPECIAL)
ATTN: JOHN  CHEN                  PHONE NO : 886 285 122747
7F,86,SEC.1, KWANG FU ROAD        SE DECISION MADE: 18-OCT-04
SAN CHUNG CITY, CHINA (TAIWAN) 241510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: AUTO THERM 390, MODEL ME 390
METTLER ELECTRONICS CORP.         510(k) NO: K042554(ABBREVIATED)
ATTN: ROBERT E FLEMING            PHONE NO : 800-854-9305
1333 SOUTH CLAUDINA ST.           SE DECISION MADE: 08-OCT-04
ANAHEIM, CA 92805                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR
MICROMEDICS, INC.                 510(k) NO: K033589(TRADITIONAL)
ATTN: CHARLES K GROTE             PHONE NO : 651-452-1977
1285 CORPORATE CENTER DR.,        SE DECISION MADE: 04-OCT-04
#150                              510(k) STATEMENT
EAGAN, MN 55121

DEVICE: MB 105 MILLENNIUM BLADES
MILLENNIUM BIOMEDICAL, INC.       510(k) NO: K041110(TRADITIONAL)
ATTN: JERRY  KAENI                PHONE NO : 909-621-7646
360 EAST BONITA AVE.              SE DECISION MADE: 13-OCT-04
POMONA, CA 91767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE
MILLIMED A/S                      510(k) NO: K042060(TRADITIONAL)
ATTN: JUDITH  DANIELSON           PHONE NO : 360-904-6512
1327 BLUEGRASS WAY                SE DECISION MADE: 06-OCT-04
GAMBRILLS, MD 21054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER
NAI TECHNOLOGY PRODUCTS           510(k) NO: K042484(TRADITIONAL)
ATTN: ROBERT E JOHNSON            PHONE NO : 909-946-0099
1342-D NORTH BENSON AVENUE        SE DECISION MADE: 20-OCT-04
UPLAND, CA 91786                  510(k) STATEMENT

DEVICE: SILICONE BLOCK
NATIONAL MEDICAL DEVICES, INC.    510(k) NO: K042380(TRADITIONAL)
ATTN: SHERRY J NULL               PHONE NO : 406-961-0102
8500 WILSHIRE BLVD.               SE DECISION MADE: 25-OCT-04
SUITE 707                         510(k) STATEMENT
BEVERLY HILLS, CA 90211

DEVICE: CAP-ONE, MODEL TG-920P
NIHON KOHDEN AMERICA, INC.        510(k) NO: K040875(TRADITIONAL)
ATTN: SERRAH  NAMINI              PHONE NO : 949-580-1555
90 ICON ST.                       SE DECISION MADE: 15-OCT-04
FOOTHILL RANCH, CA 92610-1601     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HAND STC, MODEL 60MM
NITI MEDICAL TECHNOLOGIES LTD.    510(k) NO: K042492(TRADITIONAL)
ATTN: ORLY  MAOR                  PHONE NO : 972 9 8650610
1 HATZORAN ST.                    SE DECISION MADE: 19-OCT-04
P.O. BOX 8634                     510(k) SUMMARY AVAILABLE FROM FDA
NETANYA, ISRAEL 42506

DEVICE: PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10
NOBEL BIOCARE USA, INC.           510(k) NO: K042658(TRADITIONAL)
ATTN: ELIZABETH J MASON           PHONE NO : 714-282-4800
22715 SAVI RANCH PKWY.            SE DECISION MADE: 20-OCT-04
YORBA LINDA, CA 92887             510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: CENTURION SES EPIKERATOME
NORWOOD ABBEY , LTD.              510(k) NO: K042810(SPECIAL)
ATTN: PAUL  CLARK                 PHONE NO : 613 978 27308
63 WELLS RD.                      SE DECISION MADE: 28-OCT-04
CHELSEA HGTS., VICTORIA, AUSTRALIA510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM
NOVUS MONITORING LTD              510(k) NO: K042728(TRADITIONAL)
ATTN: JUDITH E GRADY              PHONE NO : 609-936-2311
311 ENTERPRISE DRIVE              SE DECISION MADE: 22-OCT-04
PLAINSBORO, NJ 08536              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUVASIVE MAXCESS LIGHT GUIDE
NUVASIVE, INC.                    510(k) NO: K042034(TRADITIONAL)
ATTN: LAETITIA  COUSIN            PHONE NO : 858-527-1918
10065 OLD GROVE RD.               SE DECISION MADE: 26-OCT-04
SAN DIEGO, CA 92131               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PANORAMIC 200A
OPTOS PLC                         510(k) NO: K042001(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN           PHONE NO : 202-637-5813
555 THIRTEENTH ST. N.W.           SE DECISION MADE: 07-OCT-04
COLUMBIA SQUARE                   510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004-1109

DEVICE: OPUS SPEEDSTITCH SUTURE DEVICE
OPUS MEDICAL, INC.                510(k) NO: K042031(TRADITIONAL)
ATTN: LAURA N KASPEROWICZ         PHONE NO : 949-234-0400
27127 CALLE ARROYO, SUITE 1924    SE DECISION MADE: 19-OCT-04
SAN JUAN CAPISTRANO, CA 92675     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20,
ORTHO-CLINICAL DIAGNOSTICS        510(k) NO: K042494(TRADITIONAL)
ATTN: DARLENE J PHILLIPS          PHONE NO : 585-453-4253
100 INDIGO CREEK DR.              SE DECISION MADE: 19-OCT-04
ROCHESTER, NY 14626-5101          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS
ORTHO-CLINICAL DIAGNOSTICS, INC.  510(k) NO: K042006(TRADITIONAL)
ATTN: DARLENE J PHILLIPS          PHONE NO : 585-453-4253
100 INDIGO CREEK DR.              SE DECISION MADE: 28-OCT-04
ROCHESTER, NY 14626-5101          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML,
OSSACUR AG                        510(k) NO: K042305(ABBREVIATED)
ATTN: KRISTI  KISTNER             PHONE NO : 805-682-8685
975 VERONICS SPRINGS ROAD         SE DECISION MADE: 21-OCT-04
SANTA BARBARA, CA 93105           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWERED WHEELCHAIR, MODEL B-500
OTTO BOCK HEALTH CARE, LP         510(k) NO: K041208(TRADITIONAL)
ATTN: BOB  CLARKE                 PHONE NO : 763-489-5105
2 CARLSON PWY. STE. 100           SE DECISION MADE: 01-OCT-04
MINNEAPOLIS, MN 55447-4467        510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: POWERED WHEELCHAIR, MODEL B-600
OTTO BOCK HEALTH CARE, LP         510(k) NO: K041210(TRADITIONAL)
ATTN: BOB  CLARKE                 PHONE NO : 763-489-5105
2 CARLSON PWY. STE. 100           SE DECISION MADE: 01-OCT-04
MINNEAPOLIS, MN 55447-4467        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWERED WHEELCHAIR, MODEL C-1000
OTTO BOCK HEALTH CARE, LP         510(k) NO: K041211(TRADITIONAL)
ATTN: BOB  CLARKE                 PHONE NO : 763-489-5105
2 CARLSON PWY. STE. 100           SE DECISION MADE: 01-OCT-04
MINNEAPOLIS, MN 55447-4467        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WEST NILE VIRUS IGA INDIRECT ELISA
PANBIO LIMITED                    510(k) NO: K041068(TRADITIONAL)
ATTN: CRAIG  BREADMORE            PHONE NO : 617 335 71177
116 LUTWYCHE RD.                  SE DECISION MADE: 20-OCT-04
WINDSOR, BRISBANE, AUSTRALIA 4030 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PASCO MIC AND MIC/ID PANELS
PASCO LABORATORIES, INC.          510(k) NO: K042331(TRADITIONAL)
ATTN: LINDA K DILLON              PHONE NO : 303-390-3240
12750 WEST 42ND AVE.              SE DECISION MADE: 07-OCT-04
WHEAT RIDGE, CO 80033             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISC-1000 PENTAX CONFOCAL LASER SYSTEM
PENTAX MEDICAL COMPANY            510(k) NO: K042740(TRADITIONAL)
ATTN: PAUL  SILVA                 PHONE NO : 201-391-0932
102 CHESTNUT RIDGE ROAD           SE DECISION MADE: 19-OCT-04
MONTVALE, NJ 07645                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE
PENTAX MEDICAL COMPANY            510(k) NO: K042741(TRADITIONAL)
ATTN: PAUL  SILVA                 PHONE NO : 201-391-0932
102 CHESTNUT RIDGE ROAD           SE DECISION MADE: 19-OCT-04
MONTVALE, NJ 07645                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PRACTIX CONVENIO
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K042368(ABBREVIATED)
ATTN: LYNN  HARMER                PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HIGHWAY     SE DECISION MADE: 04-OCT-04
BOTHELL, WA 98021-8431            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: C-PET PLUS IMAGING SYSTEM
PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K042839(TRADITIONAL)
ATTN: RAE ANN  FARROW             PHONE NO : 440-483-2647
595 MINER RD.                     SE DECISION MADE: 29-OCT-04
CLEVELAND, OH 44143               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K042306(ABBREVIATED)
ATTN: EGON  PFEIL                 PHONE NO : 49 703 14631926
HEWLETT-PACKARD STR.2             SE DECISION MADE: 15-OCT-04
BOEBLINGEN, GERMANY D 71034       510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: PHILIPS IU22 ULTRASOUND SYSTEM
PHILIPS ULTRASOUND, INC.          510(k) NO: K042540(TRADITIONAL)
ATTN: LYNN  HARMER                PHONE NO : 425-487-7312
2722 S. FAIRVIEW                  SE DECISION MADE: 04-OCT-04
SANTA ANA, CA 92704               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: XTRAC XL, MODEL AL8000
PHOTO MEDEX, INC.                 510(k) NO: K041943(TRADITIONAL)
ATTN: BOB  ROSE                   PHONE NO : 760-602-3300
2431 IMPALA DR.                   SE DECISION MADE: 14-OCT-04
CARLSBAD, CA 92008-7227           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLYMEDCO OC AUTO MICRO FOB TEST
POLYMEDCO, INC.                   510(k) NO: K041408(TRADITIONAL)
ATTN: HELEN  LANDICHO             PHONE NO : 425-814-1514
510 FURNACE DOCK RD.              SE DECISION MADE: 21-OCT-04
CORTLANDT MANOR, NY 10567         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRECISION LIQUID OXYGEN SYSTEM
PRECISION MEDICAL, INC.           510(k) NO: K041122(TRADITIONAL)
ATTN: JAMES  PARKER               PHONE NO : 610-262-6090
300 HELD DR.                      SE DECISION MADE: 04-OCT-04
NORTHAMPTON, PA 18067             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LITESTREAM 500E
PRIDE MOBILITY PRODUCTS CORP.     510(k) NO: K042444(TRADITIONAL)
ATTN: THOMAS  SCHAPPERT           PHONE NO : 570-655-5574
182 SUSQUEHANNA AVE.              SE DECISION MADE: 21-OCT-04
EXETER, PA 18643                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JAZZY 600
PRIDE MOBILITY PRODUCTS CORP.     510(k) NO: K042612(SPECIAL)
ATTN: THOMAS J SCHAPPERT          PHONE NO : 570-655-5574
182 SUSQUEHANNA AVE.              SE DECISION MADE: 06-OCT-04
EXETER, PA 18643                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS A
PROMEDICAL PRODUCTS CO., LTD.     510(k) NO: K042137(TRADITIONAL)
ATTN: BOYD  HARRIS                PHONE NO : 662-312-0898
125 CLEMENTS AVE.                 SE DECISION MADE: 05-OCT-04
STARKVILLE, MS 39759              510(k) STATEMENT

DEVICE: QRS-CARD CARDIOLOGY SUITE
PULSE BIOMEDICAL, INC.            510(k) NO: K042799(TRADITIONAL)
ATTN: SALEEM  HASAN               PHONE NO : 610-666-5510
935 SOUTH TROOPER RD.             SE DECISION MADE: 22-OCT-04
NORRISTOWN, PA 19403              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: QUILL SYNTHETIC ABSORBABLE BARBED SUTURE
QUILL MEDICAL, INC.               510(k) NO: K042075(TRADITIONAL)
ATTN: JOHN F SCHAEFER             PHONE NO : 201-818-6777
1600 STEWART AVE.                 SE DECISION MADE: 26-OCT-04
WESTBURY, NY 11590                510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE
RADIANT MEDICAL                   510(k) NO: K042388(TRADITIONAL)
ATTN: ANDREW  CLEELAND            PHONE NO : 650-298-0733
250 CHESAPEAKE DR.                SE DECISION MADE: 28-OCT-04
REDWOOD CITY, CA 94063            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABL800 FLEX
RADIOMETER MEDICAL APS            510(k) NO: K041874(TRADITIONAL)
ATTN: LENE M MARNAES              PHONE NO : 45 382 73827
AKANDEVEJ 21                      SE DECISION MADE: 08-OCT-04
BRONSHOJ, DENMARK DK-2700         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IPACS CARDIO
REAL TIME IMAGE INC.              510(k) NO: K042781(TRADITIONAL)
ATTN: CARL  ALLETTO               PHONE NO : 904-300-8601
1600 MANCHESTER WAY               SE DECISION MADE: 19-OCT-04
CORINTH, TX 76210                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER)
REICHERT INC.                     510(k) NO: K042831(TRADITIONAL)
ATTN: FRANK J DREXELIUS           PHONE NO : 716-686-4548
3374 WALDEN AVE.                  SE DECISION MADE: 28-OCT-04
DEPEW, NY 14043                   510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: MIRAGE SWIFT
RESMED LTD.                       510(k) NO: K042403(TRADITIONAL)
ATTN: DAVID  D'CRUZ               PHONE NO : 858-746-2238
14040 DANIELSON ST.               SE DECISION MADE: 08-OCT-04
POWAY, CA 92064-6857              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS
RESPIRONICS NEW JERSEY, INC.      510(k) NO: K042655(TRADITIONAL)
ATTN: LAUREN  ZIEGLER             PHONE NO : 973-571-2608
41 CANFIELD RD.                   SE DECISION MADE: 13-OCT-04
CEDAR GROVE, NJ 07009-1201        510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ANTI-SNORING/SLEEP APNEA DEVICE
RJ & VK BIRD PTY LTD.             510(k) NO: K042161(TRADITIONAL)
ATTN: JONATHON  BIRD              PHONE NO : 011 613 96909898
25 MILLS STREET                   SE DECISION MADE: 27-OCT-04
MIDDLE PARK, VICTORIA, AUSTRALIA 3510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX
ROCHE DIAGNOSTICS CORP.           510(k) NO: K042485(TRADITIONAL)
ATTN: THERESA M AMBROSE           PHONE NO : 317-521-3723
9115 HAGUE RD.                    SE DECISION MADE: 29-OCT-04
INDIANAPOLIS, IN 46250            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOMETRIAL SAMPLING SYRINGE
ROCKET MEDICAL PLC                510(k) NO: K040189(TRADITIONAL)
ATTN: R.  KEEN                    PHONE NO : 203-329-2700
1151 HOPE ST.                     SE DECISION MADE: 04-OCT-04
STAMFORD, CT 06907                510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: SLEEPSENSE SLEEP SENSORS
S.L.P. LTD.                       510(k) NO: K042253(TRADITIONAL)
ATTN: NOAM  HADAS                 PHONE NO : 972 3 5371281
18 HAZFIRA ST.                    SE DECISION MADE: 06-OCT-04
TEL-AVIV, ISRAEL 67779            510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM
SAFETY SYRINGES, INC.             510(k) NO: K042712(SPECIAL)
ATTN: THOMAS L HALL               PHONE NO : 760-918-9908
1939 PALOMAR OAKS WAY, SUITE A    SE DECISION MADE: 15-OCT-04
CARLSBAD, CA 92009                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT)
SANDSTONE MEDICAL TECHNOLOGIES, LL510(k) NO: K040563(TRADITIONAL)
ATTN: CONNIE  WHITE HOY           PHONE NO : 530-666-7616
908 STETSON STREET                SE DECISION MADE: 08-OCT-04
WOODLAND, CA 95776                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VARICES NEEDLE
SCANDIMED. A.S.                   510(k) NO: K031238(TRADITIONAL)
ATTN: COURTNEY  SMITH             PHONE NO : 610-539-9300
280 GODSHALL RD                   SE DECISION MADE: 04-OCT-04
COLLEGEVILLE, PA 19426            510(k) STATEMENT

DEVICE: SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM
SCANDIUS BIOMEDICAL, INC.         510(k) NO: K041961(TRADITIONAL)
ATTN: ERIC  BANNON                PHONE NO : 978-486-4088
11A BEAVER BROOK ROAD             SE DECISION MADE: 20-OCT-04
LITTLETON, MA 01460               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING
SELECT FABRICATORS, INC.          510(k) NO: K040518(TRADITIONAL)
ATTN: JOSEPH M AZARY              PHONE NO : 203-944-9320
P.O. BOX 2156                     SE DECISION MADE: 27-OCT-04
HUNTINGTON, CT 06484              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLARITY FUSION
SHARED P.E.T. IMAGING, LLC        510(k) NO: K042692(SPECIAL)
ATTN: RUSS  PAGANO                PHONE NO : 202-546-1262
710 A STREET, NE                  SE DECISION MADE: 07-OCT-04
WASHINGTON, DC 20002              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHIAN JIA MEEI DIGATAL PWN TENS, MODEL YW-6000/UC-332/UC-330/ST-
SHIAN JIA MEEI ENTERPRISE CO., LTD510(k) NO: K040311(TRADITIONAL)
ATTN: JENNIFER  REICH             PHONE NO : 928-773-9488
3892 SOUTH AMERICA WEST TRAIL     SE DECISION MADE: 01-OCT-04
FLAGGSTAF, AZ 86001               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
SIEMENS AG, MEDICAL SOLUTIONS     510(k) NO: K042605(SPECIAL)
ATTN: RUDIGER  KORNER             PHONE NO : 499 191 189355
HENKESTRASSE 127                  SE DECISION MADE: 08-OCT-04
ERLANGEN, GERMANY 91052           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

 
DEVICE: SIENET COSMOS (VERSION V15A)
SIEMENS AG, MEDICAL SOLUTIONS     510(k) NO: K042832(TRADITIONAL)
ATTN: EVA  REITER                 PHONE NO : +49 913 1842680
HENKESTRASSE 127                  SE DECISION MADE: 28-OCT-04
ERLANGEN, GERMANY D-91052         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ACUSON ACUNAV 8F ULTRASOUND CATHETER
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K042593(SPECIAL)
ATTN: ISKRA  MARKOVIC             PHONE NO : 650-694-5004
1230 SHOREBIRD WAY                SE DECISION MADE: 15-OCT-04
P O BOX 7393                      510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94039-7393

DEVICE: MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K042770(TRADITIONAL)
ATTN: PATRICK  LYNCH              PHONE NO : 425-557-1825
22010 S.E. 51ST ST.               SE DECISION MADE: 20-OCT-04
ISSAQUAH, WA 98029                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K042833(TRADITIONAL)
ATTN: PATRICK J LYNCH             PHONE NO : 425-557-1825
22010 S.E. 51ST ST.               SE DECISION MADE: 27-OCT-04
ISSAQUAH, WA 98029                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTER
SIEMENS MEDICAL SOLUTIONS, INC.   510(k) NO: K042793(SPECIAL)
ATTN: DEBBIE  PEACOCK             PHONE NO : 610-448-1773
51 VALLEY STREAM PARKWAY          SE DECISION MADE: 29-OCT-04
E-50                              510(k) SUMMARY AVAILABLE FROM FDA
MALVERN, PA 19355

DEVICE: DYNACT
SIEMENS MEDICAL SYSTEMS, INC.     510(k) NO: K042646(SPECIAL)
ATTN: ANA  LADINO                 PHONE NO : 610-448-1785
51 VALLEY STREAM PARKWAY          SE DECISION MADE: 19-OCT-04
MALVERN, PA 19355                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IUR RECIPROCATING MORCELLATOR MODEL # 7210517
SMITH & NEPHEW, INC.              510(k) NO: K041774(TRADITIONAL)
ATTN: JANICE  HASELTON            PHONE NO : 978-749-1494
150 MINUTEMAN ROAD                SE DECISION MADE: 07-OCT-04
ANDOVER, MA 01810                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IIIZAROV PULLEY SYSTEM
SMITH & NEPHEW, INC.              510(k) NO: K042436(TRADITIONAL)
ATTN: JOHN  REABE                 PHONE NO : 901-399-6670
1450 E. BROOKS RD.                SE DECISION MADE: 07-OCT-04
MEMPHIS, TN 38116                 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: CLEO 90 INFUSION SET
SMITHS MEDICAL MD, INC.           510(k) NO: K042172(TRADITIONAL)
ATTN: DAVID H SHORT               PHONE NO : 651-628-7240
1265 GREY FOX ROAD                SE DECISION MADE: 07-OCT-04
ST. PAUL, MN 55112                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONOSCAPE ULTRASOUND SYSTEM SSI-1000/SSI-5000
SONOSCAPE COMPANY LIMITED         510(k) NO: K042369(TRADITIONAL)
ATTN: BOB  LEIKER                 PHONE NO : 925-556-1302
7263 CRONIN CIRCLE                SE DECISION MADE: 20-OCT-04
DUBLIN, CA 94568                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
STANBIO LABORATORY                510(k) NO: K041155(TRADITIONAL)
ATTN: ADAOBI  OGUCHI              PHONE NO : 830-249-0772
1261 NORTH MAIN ST.               SE DECISION MADE: 14-OCT-04
BOERNE, TX 78006                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001
STARGATE INTERNATIONAL, INC.      510(k) NO: K041530(TRADITIONAL)
ATTN: ROBERT H WALKER             PHONE NO : 303-840-8206
10235 SOUTH PROGRESS WAY, #7      SE DECISION MADE: 14-OCT-04
PARKER, CO 80134                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STAT K IN VITRO DIAGNOSTIC TEST SYSTEM
STAT CHEM, INC.                   510(k) NO: K042270(TRADITIONAL)
ATTN: MARTIN J PATKO              PHONE NO : 714-634-8456
619 NORTH POPLAR STREET           SE DECISION MADE: 06-OCT-04
ORANGE, CA 92868                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM
STERNGOLD                         510(k) NO: K041271(ABBREVIATED)
ATTN: PAMELA  PAPINEAU            PHONE NO : 978-772-3552
5 WHITCOMB AVE.                   SE DECISION MADE: 28-OCT-04
AYER, MA 01432                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RETIC-CHEX FOR CELL-DYN
STRECK LABORATORIES, INC.         510(k) NO: K042587(TRADITIONAL)
ATTN: KERRIE  OETTER              PHONE NO : 402-537-5215
7002 SOUTH 109TH ST.              SE DECISION MADE: 19-OCT-04
LA VISTA, NE 68128                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PAINPUMP1; PAINPUMP2
STRYKER CORP.                     510(k) NO: K042405(TRADITIONAL)
ATTN: JENNIFER  MARS              PHONE NO : 269-323-7700
4100 E. MILHAM AVE.               SE DECISION MADE: 14-OCT-04
KALAMAZOO, MI 49001               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VACUUM ASSISTED CORE BIOPSY DEVICE
SUROS SURGICAL SYSTEMS, INC.      510(k) NO: K042290(TRADITIONAL)
ATTN: JOSEPH  MARK                PHONE NO : 317-344-7500
9502 ANGOLA COURT SUITE 3         SE DECISION MADE: 06-OCT-04
INDIANAPOLIS, IN 46268            510(k) STATEMENT

 
DEVICE: POLYVAC INSTRUMENT DELIVERY SYSTEM
SYMMETRY MEDICAL USA INC.         510(k) NO: K040223(TRADITIONAL)
ATTN: DAVID  FURR                 PHONE NO : 360-459-9475
7822 LADUE GLEN                   SE DECISION MADE: 22-OCT-04
FORT WAYNE, IN 46804              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AURORA DS
SYNERON MEDICAL LTD.              510(k) NO: K041969(TRADITIONAL)
ATTN: AMIR  WALDMAN               PHONE NO : 972 674 04616
POB 550                           SE DECISION MADE: 19-OCT-04
YOKNEAM ELITE, ISRAEL 20692       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD
SYNOVIS SURGICAL INNOVATIONS      510(k) NO: K041669(TRADITIONAL)
ATTN: JAMES  JENKINS              PHONE NO : 651-796-7368
2575 UNIVERSITY AVE. WEST         SE DECISION MADE: 27-OCT-04
ST. PAUL, MN 55114-1024           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BP-SPECT V1.O
SYNTERMED, INC.                   510(k) NO: K042258(TRADITIONAL)
ATTN: KENNETH F VAN TRAIN         PHONE NO : 714-281-1256
245 OWENS DR.                     SE DECISION MADE: 04-OCT-04
ANAHEIM, CA 92808                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXT
SYNTHES (USA)                     510(k) NO: K042135(TRADITIONAL)
ATTN: LISA M BOYLE                PHONE NO : 610-647-9700
P.O. BOX 1766                     SE DECISION MADE: 07-OCT-04
1690 RUSSELL ROAD                 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222

DEVICE: SYNTHES (USA) LCP WRIST FUSION PLATES
SYNTHES (USA)                     510(k) NO: K042355(TRADITIONAL)
ATTN: SHERI L MUSGNUNG            PHONE NO : 610-647-9700
1690 RUSSELL RD.                  SE DECISION MADE: 27-OCT-04
PAOLI, PA 19301                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS
SYNTHES (USA)                     510(k) NO: K042356(TRADITIONAL)
ATTN: LISA M BOYLE                PHONE NO : 610-647-9700
1690 RUSSELL RD.                  SE DECISION MADE: 07-OCT-04
PAOLI, PA 19301                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES LOW PROFILE RECONSTRUCTION PLATES
SYNTHES (USA)                     510(k) NO: K042377(TRADITIONAL)
ATTN: LISA M BOYLE                PHONE NO : 610-647-9700
1690 RUSSELL RD.                  SE DECISION MADE: 07-OCT-04
PAOLI, PA 19301                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES CONTOURED SYNMESH SPACER
SYNTHES SPINE                     510(k) NO: K041389(SPECIAL)
ATTN: ANGELA  MIKROULIS           PHONE NO : 484-356-9616
1230 WILSON DRIVE                 SE DECISION MADE: 01-OCT-04
WEST CHESTER, PA 19380            510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: IBD-SCAN
TECHLAB, INC.                     510(k) NO: K042071(TRADITIONAL)
ATTN: DAVID M LYERLY              PHONE NO : 540-953-1664
2001 KRAFT DR.                    SE DECISION MADE: 20-OCT-04
BLACKSBURG, VA 24060-6358         510(k) STATEMENT

DEVICE: SMK, CX, CXE, RCN
TECHNOMED EUROPE                  510(k) NO: K042375(TRADITIONAL)
ATTN: RENE  RONCKEN               PHONE NO : 31 43 4086868
AMERIKALAAN 71                    SE DECISION MADE: 26-OCT-04
MAASTRICHT AIRPORT, NETHERLANDS 61510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TECNO REUSABLE BIPOLAR CABLES, MODEL 190-100 AND 190-110
TECNO INSTRUMENTS (PVT.) LTD.     510(k) NO: K042608(TRADITIONAL)
ATTN: MOHAN  RATANCHANDANI        PHONE NO : 516-482-9001
55 NORTHERN BLVD., SUITE 200      SE DECISION MADE: 18-OCT-04
GREAT NECK,, NY 11021             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FOUNDATION
TERUMO CORP.                      510(k) NO: K040783(TRADITIONAL)
ATTN: KEITH A BARRITT, ESQ.       PHONE NO : 202-783-5070
1425 K STREET N.W.                SE DECISION MADE: 13-OCT-04
SUITE 1100                        510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005

DEVICE: ADVENTURE A10
ULRICH ALBER GMBH                 510(k) NO: K042535(TRADITIONAL)
ATTN: RALF  LEDDA                 PHONE NO : 074 321 0060
VOR DEM WEISSEN STEIN 21          SE DECISION MADE: 05-OCT-04
ALBSTADT-TAILFINGEN, GERMANY D-724510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ENDOREZ
ULTRADENT PRODUCTS, INC.          510(k) NO: K042756(SPECIAL)
ATTN: TAMMY  LAVERY               PHONE NO : 801-553-4200
505 WEST 10200 SOUTH              SE DECISION MADE: 26-OCT-04
SOUTH JORDAN, UT 84095            510(k) STATEMENT

DEVICE: UNFORS PATIENT SKIN DOSIMETER (PSD)
UNFORS INC.                       510(k) NO: K042698(TRADITIONAL)
ATTN: PATRICK R PYERS             PHONE NO : 860-355-2588
123 LITCHFIELD RD.                SE DECISION MADE: 22-OCT-04
NEW MILFORD, CT 06776             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED
VALLEY FORGE SCIENTIFIC CORP.     510(k) NO: K042604(SPECIAL)
ATTN: JERRY L MALIS               PHONE NO : 610-666-7500
136 GREEN TREE RD.                SE DECISION MADE: 22-OCT-04
P.O. BOX 1179                     510(k) SUMMARY AVAILABLE FROM FDA
OAKS, PA 19456

DEVICE: ON-BOARD IMAGER DEVICE
VARIAN MEDICAL SYSTEMS            510(k) NO: K042720(SPECIAL)
ATTN: VY  TRAN                    PHONE NO : 650-424-5731
3100 HANSEN WAY                   SE DECISION MADE: 29-OCT-04
M/S E-110                         510(k) SUMMARY AVAILABLE FROM FDA
PALO ALTO, CA 94304-1129

 
DEVICE: HDS INTRA-ORAL IMAGING SYSTEM
VATECH VALUE ADDED TECHNOLOGY CO.,510(k) NO: K042372(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 847-374-1727
P.O. BOX 7007                     SE DECISION MADE: 04-OCT-04
DEERFIELD, IL 60015               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JEJE TEETHER
VIBE 2000                         510(k) NO: K034017(TRADITIONAL)
ATTN: CAROL  PATTERSON            PHONE NO : 949-462-0900
21911 ERIE LANE                   SE DECISION MADE: 18-OCT-04
LAKE FOREST, CA 93030             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISTAKON (SENOFILCON A) SOFT CONTACT LENS
VISTAKON                          510(k) NO: K042275(TRADITIONAL)
ATTN: ANNETTE M HILLRING          PHONE NO : 813-269-8246
3012 ST. CHARLES DR.              SE DECISION MADE: 28-OCT-04
TAMPA, FL 33618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IONOFIL PLUS AC
VOCO GMBH                         510(k) NO: K042669(SPECIAL)
ATTN: GERALD W SHIPPS             PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP              SE DECISION MADE: 20-OCT-04
BEND, OR 97702                    510(k) STATEMENT

DEVICE: URO PRO
W.O.M. WORLD OF MEDICINE AG       510(k) NO: K042457(TRADITIONAL)
ATTN: SUSANNE  RAAB               PHONE NO : 781-749-4656
119 SOUTH ST.                     SE DECISION MADE: 25-OCT-04
HINGHAM, MA 02043                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RM3 RENAL PRESERVATION SYSTEM
WATERS INSTRUMENTS, INC.          510(k) NO: K042224(SPECIAL)
ATTN: DAVE  SCHOLLMAN             PHONE NO : 763-509-7423
13705 26TH AVENUE N.              SE DECISION MADE: 22-OCT-04
SUITE 102                         510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55441-3644

DEVICE: WIDE 1MP LCD MONITOR SYSTEM
WIDE CORPORATION                  510(k) NO: K042634(TRADITIONAL)
ATTN: CARL  ALLETTO               PHONE NO : 940-300-8601
1100 LAKEVIEW BLVD.               SE DECISION MADE: 08-OCT-04
DENTON, TX 76208                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: LOCON VLS DISTAL RADIUS PLATE SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K042358(SPECIAL)
ATTN: JEANINE H REDDEN            PHONE NO : 901-867-4522
5677 AIRLINE RD.                  SE DECISION MADE: 07-OCT-04
ARLINGTON, TN 38002               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMLUCK, YA HORNG
YA HORNG ELECTRONIC CO., LTD.     510(k) NO: K042581(TRADITIONAL)
ATTN: JEN  KE-MIN                 PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST.              SE DECISION MADE: 13-OCT-04
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: ATHENA MULTI-LYTE ANA-II TEST SYSTEM
ZEUS SCIENTIFIC, INC.             510(k) NO: K042416(SPECIAL)
ATTN: MARK J KOPNITSKY            PHONE NO : 908-526-3744
P.O. BOX 38                       SE DECISION MADE: 08-OCT-04
RARITAN, NJ 08869                 510(k) STATEMENT

DEVICE: NCB PLATING SYSTEM
ZIMMER GMBH                       510(k) NO: K042695(TRADITIONAL)
ATTN: STEPHEN H MCKELVEY          PHONE NO : 574-372-4944
P.O. BOX 708                      SE DECISION MADE: 29-OCT-04
WARSAW, IN 46581-0708             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE C
ZIMMER, INC.                      510(k) NO: K041100(SPECIAL)
ATTN: DALENE T BINKLEY            PHONE NO : 574-372-4907
P.O. BOX 708                      SE DECISION MADE: 29-OCT-04
WARSAW, IN 46581-0708             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEMOVAC BLOOD REINFUSION SYSTEM
ZIMMER, INC.                      510(k) NO: K041525(TRADITIONAL)
ATTN: CINDY J DICKEY              PHONE NO : 330-364-9493
PO BOX 10 200 W. OHIO AVENUE      SE DECISION MADE: 14-OCT-04
DOVER, OH 44622-0010              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKE
ZIMMER, INC.                      510(k) NO: K042271(SPECIAL)
ATTN: BRANDON  HIPSHER            PHONE NO : 574-371-8083
P.O. BOX 708                      SE DECISION MADE: 13-OCT-04
WARSAW, IN 46581-0708             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES
ZIMMER, INC.                      510(k) NO: K042598(TRADITIONAL)
ATTN: NOAH  BARTSCH               PHONE NO : 574-371-8552
P.O. BOX 708                      SE DECISION MADE: 29-OCT-04
WARSAW, IN 46581-0708             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL H
ZOLL MEDICAL CORP.                510(k) NO: K042302(SPECIAL)
ATTN: SEAN  REYNOLDS              PHONE NO : 978-421-9386
269 MILL ROAD                     SE DECISION MADE: 26-OCT-04
CHELMSFORD, MA 01824-4105         510(k) STATEMENT

DEVICE: ZOLL M SERIES ETC02 LOFLO OPTION
ZOLL MEDICAL CORP.                510(k) NO: K042417(SPECIAL)
ATTN: SEAN  REYNOLDS              PHONE NO : 978-421-9386
269 MILL ROAD                     SE DECISION MADE: 05-OCT-04
CHELMSFORD, MA 01824-4105         510(k) SUMMARY AVAILABLE FROM FDA


 
                                                TOTAL 510(k)s THIS PERIOD   277
                                                TOTAL WITH SUMMARIES        240
                                                TOTAL WITH STATEMENTS        37
Updated November 5, 2004
horizonal rule
Center for Devices and Radiological Health / CDRH