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510(k)s Final Decisions Rendered for September 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-SEP-2004 THROUGH 30-SEP-2004
DEVICE: ABBOTT AXSYM TROPONIN-I ADV
ABBOTT LABORATORIES 510(k) NO: K041811(TRADITIONAL)
ATTN: MARGARET PROCHNIAK PHONE NO : 847-937-4106
DEPT. 9V6, BLDG. AP6C-3 SE DECISION MADE: 10-SEP-04
100 ABBOTT PARK ROAD 510(k) SUMMARY AVAILABLE FROM FDA
ABBOTT PARK, IL 60064-6095
DEVICE: ROBOCOUCH PATIENT SUPPORT SYSTEM
ACCURAY INCORPORATED 510(k) NO: K042146(TRADITIONAL)
ATTN: ANNE SCHLAGENHAFT PHONE NO : 408-716-4628
1310 CHESAPEAKE TERRACE SE DECISION MADE: 17-SEP-04
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
ACMI CORPORATION 510(k) NO: K042225(SPECIAL)
ATTN: TERRENCE E SULLIVAN PHONE NO : 508-804-2600
136 TURNPIKE RD. SE DECISION MADE: 10-SEP-04
SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON TRI-FECT DRUG SCREEN TEST DEVICE
ACON LABORATORIES, INC. 510(k) NO: K041743(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 09-SEP-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE
ACON LABORATORIES, INC. 510(k) NO: K041822(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 16-SEP-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST
ACON LABORATORIES, INC. 510(k) NO: K042151(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 09-SEP-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILVERSITE OR CALGITROL
ADRI 510(k) NO: K041268(TRADITIONAL)
ATTN: GEORGE H SCHERR, PH.D. PHONE NO : 708-747-3717
232 MAIN STREET SUITE 11A SE DECISION MADE: 20-SEP-04
PARK FOREST, IL 60466 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AURA CPAP PATIENT INTERFACE
AEIOMED INC. 510(k) NO: K042130(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 08-SEP-04
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADDY
AFIKIM ELECTRIC VEHICLES 510(k) NO: K041186(TRADITIONAL)
ATTN: AVNER FISHBEIN PHONE NO : 011 972 46754814
SE DECISION MADE: 09-SEP-04
510(k) STATEMENT
DEVICE: CLARISSA INFANT NCPAP CANNULA
AIRWAYS LTD., INC. 510(k) NO: K032922(TRADITIONAL)
ATTN: RICHARD J LARKIN PHONE NO : 973-889-3611
P.O.BOX 558 SE DECISION MADE: 22-SEP-04
CEDAR KNOLLS, NJ 07927 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES
ALDEN OPTICAL LABS., INC. 510(k) NO: K042242(SPECIAL)
ATTN: CHARLES H CREIGHTON PHONE NO : 716-937-9181
13295 BROADWAY SE DECISION MADE: 15-SEP-04
ALDEN, NY 14004 510(k) STATEMENT
DEVICE: AMBU DISPOSABLE ECG ELECTRODE
AMBU, INC. 510(k) NO: K041734(TRADITIONAL)
ATTN: SANJAY PARIKH PHONE NO : 410-636-1144
611 NORTH HAMMONDS FERRY ROAD SE DECISION MADE: 22-SEP-04
LINTHICUM, MD 21090-1356 510(k) STATEMENT
DEVICE: AMERICAN DENTAL IMPLANT
AMERICAN DENTAL IMPLANT CORPORATIO510(k) NO: K042462(TRADITIONAL)
ATTN: STEVEN B LOMBARDI PHONE NO : 724-652-3241
2415 WILMINGTON RD. SE DECISION MADE: 21-SEP-04
NEW CASTLE, PA 16105 510(k) STATEMENT
DEVICE: TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
AMERICAN I.V. PRODUCTS, INC. 510(k) NO: K040392(TRADITIONAL)
ATTN: GREGORY FALK PHONE NO : 410-787-1300
7485 SHIPLEY AVE. SE DECISION MADE: 14-SEP-04
HANOVER, MD 21076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMPLIFE DIGITAL CLINICAL THERMOMETER
AMPLIFE CORPORATION 510(k) NO: K042575(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 30-SEP-04
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: IMPLANTEO IMPLANTOLOGY MOTOR
ANTHOGYR 510(k) NO: K041279(ABBREVIATED)
ATTN: ERIC GENEVE PHONE NO : 33 4 50580237
164 RUE DE TROIS LACS SE DECISION MADE: 23-SEP-04
SALLANCHES, FRANCE 74700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOSURG ULTRASONIC SURGICAL SYSTEM
AOMORI OLYMPUS CO., LTD. 510(k) NO: K041566(TRADITIONAL)
ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477
2 CORPORATE CENTER DR. SE DECISION MADE: 08-SEP-04
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO OPTICAL SEPARATOR SYSTEM
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K041795(TRADITIONAL)
ATTN: CHERYL BLAKE PHONE NO : 949-713-8327
22872 AVENIDA EMPRESSA SE DECISION MADE: 14-SEP-04
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX HUMERAL FRACTURE PLATES AND SCREWS
ARTHREX, INC. 510(k) NO: K041965(TRADITIONAL)
ATTN: SALLY FOUST PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 08-SEP-04
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTELON SPACER CMC-1
ARTIMPLANT AB 510(k) NO: K040070(TRADITIONAL)
ATTN: MARIE MARLOW PHONE NO : 202-546-1262
719 A STREET NE SE DECISION MADE: 21-SEP-04
WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT
ATRIUM MEDICAL CORP. 510(k) NO: K041269(TRADITIONAL)
ATTN: JOSEPH P DE PAOLO PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 14-SEP-04
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA
AXIS-SHIELD DIAGNOSTICS, LTD. 510(k) NO: K041866(TRADITIONAL)
ATTN: SUSAN LEONARD PHONE NO : 44 13 82422000
THE TECHNOLOGY PARK SE DECISION MADE: 29-SEP-04
DUNDEE, SCOTLAND, UNITED KINGDOM D510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIFIX CATHETER AND CONTIPLEX CATHETER
B. BRAUN MEDICAL, INC. 510(k) NO: K042488(TRADITIONAL)
ATTN: AMY SMITH PHONE NO : 601-266-0500
901 MARCON BLVD. SE DECISION MADE: 30-SEP-04
ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLIPPER DIAGNOSTIC ELECTRODE CATHETER
BARD ELECTROPHYSIOLOGY 510(k) NO: K042105(SPECIAL)
ATTN: DEBORAH L HERRINGTON PHONE NO : 978-323-2216
55 TECHNOLOGY DR. SE DECISION MADE: 23-SEP-04
LOWELL, MA 01851 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE
BARD PERIPHERAL VASCULAR, INC. 510(k) NO: K042062(TRADITIONAL)
ATTN: SHARI ALLEN PHONE NO : 480-894-9515
1625 WEST 3RD ST. SE DECISION MADE: 30-SEP-04
TEMPE, AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOS
BAYER HEALTHCARE, DIAGNOSTICS DIVI510(k) NO: K042015(TRADITIONAL)
ATTN: ANDRES HOLLE PHONE NO : 914-524-3494
511 BENEDICT AVE. SE DECISION MADE: 29-SEP-04
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
BAYER HEALTHCARE, LLC 510(k) NO: K042251(SPECIAL)
ATTN: ANDRES HOLLE PHONE NO : 914-524-2531
511 BENEDICT AVE. SE DECISION MADE: 17-SEP-04
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD FACSCANTO WITH BD FACSANTO SOFTWARE
BD BIOSCIENCES 510(k) NO: K041074(TRADITIONAL)
ATTN: KIM FONDA PHONE NO : 408-954-2329
2350 QUME DR. SE DECISION MADE: 17-SEP-04
SAN JOSE, CA 95131-1807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID P
BECKMAN COULTER, INC. 510(k) NO: K042195(TRADITIONAL)
ATTN: KIM WALKER PHONE NO : 714-961-4912
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 16-SEP-04
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
BECKMAN COULTER, INC. 510(k) NO: K042281(SPECIAL)
ATTN: BARBARA STEGMEIER PHONE NO : 952-368-7648
1000 LAKE HAZELTINE DR. SE DECISION MADE: 16-SEP-04
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD FACS 7-COLOR SETUP BEADS
BECTON DICKINSON IMMUNOCYTOMETRY S510(k) NO: K040026(TRADITIONAL)
ATTN: CINDY MORROW PHONE NO : 408-954-2694
2350 QUME DR. SE DECISION MADE: 10-SEP-04
SAN JOSE, CA 95131-1807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD FACSCANTO SYSTEM
BECTON DICKINSON IMMUNOCYTOMETRY S510(k) NO: K040725(TRADITIONAL)
ATTN: KIM FONDA PHONE NO : 408-432-9475
2350 QUME DR. SE DECISION MADE: 10-SEP-04
SAN JOSE, CA 95131-1807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTENS ELECTRODE
BIO PROTECH, INC. 510(k) NO: K042301(TRADITIONAL)
ATTN: E.J. EDWARD PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 03-SEP-04
CROFTON, MD 21114 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL P
BIO-RAD LABORATORIES, INC. 510(k) NO: K042335(TRADITIONAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367
9500 JERONIMO RD. SE DECISION MADE: 17-SEP-04
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE PRODIGY SYSTEM DENTAL IMPLANTS
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K042429(SPECIAL)
ATTN: WINSTON GREER PHONE NO : 205-967-7880
ONE PERIMETER PARK SOUTH SE DECISION MADE: 16-SEP-04
SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
BIRMINGHAM, AL 35243
DEVICE: FIDIS CELIAC
BIOMEDICAL DIAGNOSTICS S.A. 510(k) NO: K041002(TRADITIONAL)
ATTN: PASCALE LAROCHE PHONE NO : 33 164 621012
ACTIPOLE, 25-BD DE BEAUBOURG SE DECISION MADE: 24-SEP-04
BP 103 510(k) SUMMARY AVAILABLE FROM FDA
MARNE-LA-VALLEE, CEDEX 2, FRANCE 77423
DEVICE: VITEK 2 GRAM NEGATIVE ERTAPENEM
BIOMERIEUX, INC. 510(k) NO: K041982(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695
595 ANGLUM RD. SE DECISION MADE: 14-SEP-04
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED
BIOMET MANUFACTURING CORP. 510(k) NO: K041872(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO :
56 EAST BELL DRIVE PO BX 587 SE DECISION MADE: 08-SEP-04
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPRO SUBTALAR IMPLANT
BIOPRO, INC. 510(k) NO: K041936(TRADITIONAL)
ATTN: DAVID MRAK PHONE NO : 810-982-7777
17 SEVENTEENTH ST. SE DECISION MADE: 08-SEP-04
PORT HURON, MI 48060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUET SYSTEM
BIOVIEW LTD. 510(k) NO: K040591(TRADITIONAL)
ATTN: DORIT WINITZ PHONE NO : 972 893 66868
12 HAMADA ST. SE DECISION MADE: 16-SEP-04
REHOVOT, ISRAEL 76703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VST3
BIOWATCH MEDICAL, INC. 510(k) NO: K040942(TRADITIONAL)
ATTN: URSULA E WILSON PHONE NO : 803-233-0244
1233 WASHINGTON STREET SE DECISION MADE: 15-SEP-04
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
COLUMBIA, SC 29201-3221 THIRD PARTY REVIEW
DEVICE: BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR
BLACKSTONE MEDICAL, INC. 510(k) NO: K042100(TRADITIONAL)
ATTN: DEAN CIPORKIN PHONE NO : 413-726-2513
90 BROOKSDALE DR. SE DECISION MADE: 20-SEP-04
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAVERMAP SURGICAL AID
BLUE TORCH MEDICAL TECHNOLOGIES 510(k) NO: K041732(TRADITIONAL)
ATTN: FREDERICK TOBIA PHONE NO : 508-231-1080
200 HOMER AVE ASHLAND TECH. SE DECISION MADE: 21-SEP-04
CENTER 510(k) SUMMARY AVAILABLE FROM FDA
ASHLAND, MA 01721
DEVICE: WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM
BOSTON SCIENTIFIC CORP. 510(k) NO: K042065(TRADITIONAL)
ATTN: KATHLEEN MORAHAN PHONE NO : 508-652-5942
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 30-SEP-04
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPLAN! FLOW
BRAINLAB AG 510(k) NO: K041330(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 498 999 15680
AMMERTHALSTRASSE 8 SE DECISION MADE: 22-SEP-04
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOLCUBE COOLPEN
BRUCE J. SAND M.D. 510(k) NO: K041767(TRADITIONAL)
ATTN: BRUCE J SAND, M.D. PHONE NO : 805-370-7263
638 LINDERO CANYON RD. #507 SE DECISION MADE: 30-SEP-04
OAK PARK, CA 91377 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARDEX I.C. LATEX FOLEY CATHETER
C.R. BARD, INC. 510(k) NO: K040658(TRADITIONAL)
ATTN: JOHN C KNORPP PHONE NO : 770-784-6451
8195 INDUSTRIAL BLVD. SE DECISION MADE: 29-SEP-04
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 011800
C.R. BARD, INC. 510(k) NO: K042026(TRADITIONAL)
ATTN: KAREN S GWOZDOWSKI GAUVIN PHONE NO : 401-463-7000
100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 10-SEP-04
CRANSTON, RI 02920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRONO F
CANE S.R.L. 510(k) NO: K042085(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 17-SEP-04
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMARC PRELOADED TISSUE MARKER DEVICE
CARBON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K042296(TRADITIONAL)
ATTN: ROBERT W JOHNSON PHONE NO : 651-762-2146
1290 HAMMOND RD. SE DECISION MADE: 20-SEP-04
ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISULAS YAG III
CARL ZEISS MEDITEC AG 510(k) NO: K042139(SPECIAL)
ATTN: R. MICHAEL CROMPTON PHONE NO : 925-557-4353
5160 HACIENDA DRIVE SE DECISION MADE: 09-SEP-04
DUBLIN, CA 94568-7562 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED
CENTERPULSE ORTHOPEDICS, INC. 510(k) NO: K033634(TRADITIONAL)
ATTN: AUDREY SWEARINGEN PHONE NO : 512-432-9255
9900 SPECTRUM DR. SE DECISION MADE: 15-SEP-04
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S
CHAD THERAPEUTICS, INC. 510(k) NO: K042142(SPECIAL)
ATTN: KEVIN MCCULLOH PHONE NO : 818-882-0883
21622 PLUMMER ST. SE DECISION MADE: 20-SEP-04
CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE
CHATTANOOGA GROUP 510(k) NO: K040662(TRADITIONAL)
ATTN: CHERYL BAGWELL PHONE NO : 423-870-2281
4717 ADAMS RD. SE DECISION MADE: 08-SEP-04
HIXSON, TN 37343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLAR WAND
CHEK-MED SYSTEMS 510(k) NO: K041783(TRADITIONAL)
ATTN: ROB WHALEN PHONE NO : 860-684-0030
25 VILLAGE HILL RD. SE DECISION MADE: 28-SEP-04
WILLINGTON, CT 06279 510(k) STATEMENT
DEVICE: 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
CHF SOLUTIONS, INC. 510(k) NO: K041791(TRADITIONAL)
ATTN: AMY PETERSON PHONE NO : 763-463-4620
7601 NORTHLAND DR. STE. 170 SE DECISION MADE: 10-SEP-04
BROOKLYN PARK, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOTINE MIDFACE B 4.5 DEVICE
COAPT SYSTEMS, INC. 510(k) NO: K041835(TRADITIONAL)
ATTN: LORI DONDIEGO PHONE NO : 650-461-7600
1820 EMBARCADERO RD. SE DECISION MADE: 28-SEP-04
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALUPEN,PROFILE
CONMED CORPORATION 510(k) NO: K041868(TRADITIONAL)
ATTN: PAMELA VETTER PHONE NO : 303-699-7600
14603 E. FREMONT AVE. SE DECISION MADE: 28-SEP-04
CENTENNIAL, CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOLTOUCH, MODEL NS 160
COOLTOUCH, INC. 510(k) NO: K040921(TRADITIONAL)
ATTN: DONALD V JOHNSON PHONE NO : 916-677-1900
9085 FOOTHILLS BLVD. SE DECISION MADE: 28-SEP-04
ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COSMED PONY FX
COSMED S.R.L. 510(k) NO: K040549(TRADITIONAL)
ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830
1129 BLOOMFIELD AVE. SE DECISION MADE: 28-SEP-04
WEST CALDWELL, NJ 07006 510(k) STATEMENT
DEVICE: BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)
COWELL MEDI CO LTD. 510(k) NO: K041655(ABBREVIATED)
ATTN: MARTIN J LEIGHTON PHONE NO : 603-373-0260
161 LITTLE BAY ROAD SE DECISION MADE: 08-SEP-04
NEWINGTON, NH 03801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOFIBER
CP MEDICAL 510(k) NO: K041894(SPECIAL)
ATTN: MARY ANN GREENAWALT PHONE NO : 503-232-1555
803 N.E. 25TH AVENUE SE DECISION MADE: 17-SEP-04
PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: CRESCO TI IMPLANT CONCEPT
CRESCO TI SYSTEMS AB 510(k) NO: K042354(SPECIAL)
ATTN: J. BENGTSSON PHONE NO : 464 420 8220
7 DOBELNSGATAN, BOX 571 SE DECISION MADE: 21-SEP-04
KRISTIANSTAD, SWEDEN SE-291 25 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 8600 VITAL SIGNS MONITOR
CRITICARE SYSTEMS, INC. 510(k) NO: K042569(SPECIAL)
ATTN: ALEX KAPLAN PHONE NO : 262-798-8282
20925 CROSSROADS CIRCLE SE DECISION MADE: 29-SEP-04
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15
CRYOCOR, INC. 510(k) NO: K041890(TRADITIONAL)
ATTN: JAMI MILLER PHONE NO : 858-909-2200
9717 PACIFIC HEIGHTS BLVD. SE DECISION MADE: 22-SEP-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR
DAKOCYTOMATION A/S 510(k) NO: K041627(TRADITIONAL)
ATTN: DANA OLSEN PHONE NO : 45 44 859500
42 PRODUKTIONSVEJ SE DECISION MADE: 03-SEP-04
GLOSTRUP, DENMARK DK-2600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHIN-UP STRIP
DALE MILLER, INC. - THE CHIN-UP CO510(k) NO: K040491(ABBREVIATED)
ATTN: DALE MILLER PHONE NO : 888-835-4563
1820 RIDGEMILL TERRACE SE DECISION MADE: 10-SEP-04
DRACULA, GA 30019 510(k) STATEMENT
DEVICE: DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER
DATASCOPE CORP. 510(k) NO: K042016(TRADITIONAL)
ATTN: PATRICE NAPODA PHONE NO : 201-995-8700
1300 MACARTHUR BLVD SE DECISION MADE: 23-SEP-04
MAHWAH, NJ 07430 510(k) STATEMENT
DEVICE: DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
DATEX-OHMEDA, INC. 510(k) NO: K040831(TRADITIONAL)
ATTN: SCOTT LIGHT PHONE NO : 800-652-2469
1315 WEST CENTURY DR. SE DECISION MADE: 02-SEP-04
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM
DATEX-OHMEDA, INC. 510(k) NO: K041524(TRADITIONAL)
ATTN: DAN KOSEDNAR PHONE NO : 608-221-1551
PO BOX 7550 SE DECISION MADE: 20-SEP-04
MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K042233(TRADITIONAL)
ATTN: RUTH C FORSTADT PHONE NO : 781-251-3188
249 VANDERBILT AVE. SE DECISION MADE: 28-SEP-04
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TROCHANTERIC NAIL SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K042325(SPECIAL)
ATTN: STEVE KAHN PHONE NO : 574-372-7180
700 ORTHOPAEDIC DR. SE DECISION MADE: 08-SEP-04
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: MODIFICATION TO VBR SPINAL SYSTEM
DEPUY SPINE, INC. 510(k) NO: K041722(SPECIAL)
ATTN: LISA GILMAN PHONE NO : 508-880-8287
325 PARAMOUNT DR. SE DECISION MADE: 23-SEP-04
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPEDIUM MIS SPINE SYSTEM
DEPUY SPINE, INC. 510(k) NO: K041801(TRADITIONAL)
ATTN: JENNIFER MOONEY PHONE NO : 508-828-3649
325 PARAMOUNT DR. SE DECISION MADE: 08-SEP-04
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM
DR. LEN'S MEDICAL PRODUCTS LLC 510(k) NO: K033164(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 770-777-4146
1308 MORNINGSIDE PARK DRIVE SE DECISION MADE: 07-SEP-04
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY TRIDENT NMT POD
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K042003(TRADITIONAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7503
16 ELECTRONICS AVE. SE DECISION MADE: 01-SEP-04
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D-VAPOR
DRAEGER MEDICAL, INC. 510(k) NO: K042276(TRADITIONAL)
ATTN: GALE E WINARSKY PHONE NO : 215-721-5400
3135 QUARRY RD. SE DECISION MADE: 23-SEP-04
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRADWEB MPR/MIP
DYNAMIC IMAGING INC. 510(k) NO: K042313(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1100 LAKEVIEW BLVD. SE DECISION MADE: 09-SEP-04
DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KODAK MEDICAL IMAGER 300
EASTMAN KODAK COMPANY 510(k) NO: K042158(TRADITIONAL)
ATTN: STEPHEN SLAVENS PHONE NO : 651-393-1395
1 IMATION WAY SE DECISION MADE: 24-SEP-04
304-3B-61 510(k) SUMMARY AVAILABLE FROM FDA
OAKDALE, MN 55128-3414
DEVICE: KODAK COLOR MEDICAL IMAGER 600
EASTMAN KODAK COMPANY 510(k) NO: K042159(TRADITIONAL)
ATTN: STEPHEN SLAVENS PHONE NO : 651-393-1395
1 IMATION WAY SE DECISION MADE: 24-SEP-04
304-3B-61 510(k) SUMMARY AVAILABLE FROM FDA
OAKDALE, MN 55128-3414
DEVICE: EBI PERIARTICULAR PLATING SYSTEM
EBI, L.P. 510(k) NO: K042237(TRADITIONAL)
ATTN: PETER ALLAN PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 16-SEP-04
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADENCE, MODELS 2001 AND 2002
EDAN INSTRUMENTS, INC. 510(k) NO: K040903(TRADITIONAL)
ATTN: WILLIAM STERN PHONE NO : 914-376-5200
1 ODELL PLAZA SE DECISION MADE: 02-SEP-04
YONKERS, NY 10701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIMAZE E360 SURGICAL ABLATION DEVICE
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K041739(SPECIAL)
ATTN: ELIZABETH MORAN PHONE NO : 714-250-2320
ONE EDWARDS WAY SE DECISION MADE: 29-SEP-04
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO LYSUS INFUSION SYSTEM
EKOS CORP. 510(k) NO: K042456(SPECIAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-482-1108
22030 20TH AVENUE S.E. SE DECISION MADE: 23-SEP-04
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98021
DEVICE: FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS
ELEKON INDUSTRIES U.S.A., INC. 510(k) NO: K041522(TRADITIONAL)
ATTN: KRISTA OAKES PHONE NO : 972-849-5167
2300 MCDERMOTT RD. SE DECISION MADE: 14-SEP-04
#200-207 510(k) SUMMARY AVAILABLE FROM FDA
PLANO, TX 75025
DEVICE: FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE
ELEKON INDUSTRIES U.S.A., INC. 510(k) NO: K041647(TRADITIONAL)
ATTN: KRISTA OAKES PHONE NO : 972-849-5167
2300 MCDERMOTT RD. SE DECISION MADE: 02-SEP-04
#200-207 510(k) SUMMARY AVAILABLE FROM FDA
PLANO, TX 75025
DEVICE: LEKSELL GAMMAPLAN 4C WITH MULTIVIEW
ELEKTA INSTRUMENT AB 510(k) NO: K042269(SPECIAL)
ATTN: ANDERS SKOGLUND PHONE NO : 011 46 858725400
KUNGSTENSGATAN 18 SE DECISION MADE: 08-SEP-04
PO BOX 7593 510(k) SUMMARY AVAILABLE FROM FDA
STOCKHOLM, SWEDEN SE-103 93
DEVICE: ULTRAVISUAL
EMAGEON UV, INC. 510(k) NO: K042008(TRADITIONAL)
ATTN: INGER COUTURE PHONE NO : 608-256-7775
131 W. WILSON STREET, STE.700 SE DECISION MADE: 03-SEP-04
MADISON, WI 53703-3243 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM
ENVISIONEERING, LLC. 510(k) NO: K041637(TRADITIONAL)
ATTN: TOM KAPPEL PHONE NO :
1982 INNERBELT BUSINESS CTR DR SE DECISION MADE: 01-SEP-04
ST. LOUIS, MO 63114 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TARGETSCAN BIOPSY KIT
ENVISIONEERING, LLC. 510(k) NO: K041638(TRADITIONAL)
ATTN: TOM KAPPEL PHONE NO : 314-429-7367
1982 INNERBELT BUSINESS CTR DR SE DECISION MADE: 02-SEP-04
ST. LOUIS, MO 63114 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM
ENVISIONEERING, LLC. 510(k) NO: K041639(TRADITIONAL)
ATTN: TOM KAPPEL PHONE NO : 314-429-7367
1982 INNERBELT BUSINESS CTR DR SE DECISION MADE: 02-SEP-04
ST. LOUIS, MO 63114 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EP-4 CLINICAL STIMUTATOR
EP MEDSYSTEMS 510(k) NO: K041442(SPECIAL)
ATTN: JAMES E KUHN JR. PHONE NO : 856-753-8533
COOPER RUN EXECUTIVE PARK SE DECISION MADE: 14-SEP-04
575 RT. 73 NORTH, BLDG. D 510(k) STATEMENT
WEST BERLIN, NJ 08091
DEVICE: RF INTRODUCTION CANNULA
EPIMED INTERNATIONAL, INC. 510(k) NO: K041021(TRADITIONAL)
ATTN: CHRISTOPHER B LAKE PHONE NO : 518-725-0209
141 SAL LANDRIO DR. SE DECISION MADE: 16-SEP-04
CROSSROADS BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA
JOHNSTOWN, NY 12095
DEVICE: ERCHONIA EML LASER
ERCHONIA MEDICAL, INC. 510(k) NO: K041139(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 30-SEP-04
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: X-SIZER CATHETER SYSTEM
EV3 CORPORATION 510(k) NO: K021096(TRADITIONAL)
ATTN: JILL MUNSINGER PHONE NO : 763-398-7243
4600 NATHAN LN. SE DECISION MADE: 08-SEP-04
PLYMOUTH, MN 55442-2920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXACTECH 12/14 TOTAL HIP SYSTEM
EXACTECH, INC. 510(k) NO: K041906(SPECIAL)
ATTN: GARY J MILLER PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 10-SEP-04
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XLTEK CONNEX IP HEADBOX, MODEL 1054
EXCEL TECH. LTD. 510(k) NO: K042223(SPECIAL)
ATTN: NICOLE LANDREVILLE PHONE NO : 905 829 5300
2568 BRISTOL CIRCLE SE DECISION MADE: 16-SEP-04
OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) STATEMENT
DEVICE: FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS
FOCUS MEDICAL, LLC. 510(k) NO: K041829(TRADITIONAL)
ATTN: JOHN LEE PHONE NO : 203-730-8885
23 FRANCIS J. CLARKE CIRCLE SE DECISION MADE: 07-SEP-04
BETHEL, CT 06801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K041792(TRADITIONAL)
ATTN: ARTHUR EILINSFELD PHONE NO : 781-402-9068
95 HAYDEN AVE. SE DECISION MADE: 24-SEP-04
LEXINGTON, MA 02420-9192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPITOME SYSTEM
GEBAUER MEDIZINTECHNIK GMBH 510(k) NO: K041206(TRADITIONAL)
ATTN: KIMBERLEY DONEY PHONE NO : 781-860-0388
54 FOREST STREET SE DECISION MADE: 15-SEP-04
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OP
GENERAL ELECTRIC CO. 510(k) NO: K042257(SPECIAL)
ATTN: DAVID DUERSTELER PHONE NO : 262-312-7029
P.O. BOX 414 SE DECISION MADE: 08-SEP-04
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPROCURE SUBTALAR IMPLANT SYSTEM
GRAHAM MEDICAL TECHNOLOGIES, L.L.C510(k) NO: K042030(TRADITIONAL)
ATTN: MICHAEL GRAHAM PHONE NO : 586-604-9462
45700 SCHOENHERR ROAD SE DECISION MADE: 16-SEP-04
SHELBY TOWNSHIP, MI 48315 510(k) STATEMENT
DEVICE: GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103
GUAN HONG ENTERPRISE CO., LTD. 510(k) NO: K041079(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 28-SEP-04
FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHOSAMPLER
GYNETICS MEDICAL PRODUCTS NV 510(k) NO: K041237(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 08-SEP-04
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES
GYRUS MEDICAL LTD. 510(k) NO: K041285(TRADITIONAL)
ATTN: ANDREW DZIMITROWICZ PHONE NO : 44 29 20776349
FORTRAN RD., ST. MELLONS SE DECISION MADE: 10-SEP-04
CARDIFF, UNITED KINGDOM CF3 0LT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY
HAEMOSCOPE CORP. 510(k) NO: K041502(TRADITIONAL)
ATTN: ELI COHEN PHONE NO : 847-588-0453
5693 WEST HOWARD SE DECISION MADE: 01-SEP-04
NILES, IL 60714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHOULDER FIXATION SYSTEM
HAND INNOVATIONS, INC. 510(k) NO: K042059(TRADITIONAL)
ATTN: AL WEISENBORN PHONE NO : 305-829-3437
8905 SW 87TH AVENUE SE DECISION MADE: 30-SEP-04
SUITE 220 510(k) SUMMARY AVAILABLE FROM FDA
MIAMI, FL 33176
DEVICE: INFRARED EAR THERMOMETER, ET-100 SERIES
HANGZHOU HUA'AN MEDICAL & HEALTH I510(k) NO: K041692(TRADITIONAL)
ATTN: JI BO PHONE NO : 86 571 88734065
BUILDING 2, BAIMIAO INDU. PARK SE DECISION MADE: 13-SEP-04
ECONOMIC DEVELOP. ZONE WUCHANG 510(k) STATEMENT
HANGZHOU, ZHEJIANG, CHINA 310023
DEVICE: DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL
HANGZHOU HUA'AN MEDICAL & HEALTH I510(k) NO: K041694(TRADITIONAL)
ATTN: JI BO PHONE NO : 86 571 88734065
BUILDING 2, BAIMIAO INDU. PARK SE DECISION MADE: 13-SEP-04
ECONOMIC DEVELOP. ZONE WUCHANG 510(k) STATEMENT
HANGZHOU, ZHEJIANG, CHINA 310023
DEVICE: ULTRASOUND CAPTURE SYSTEM
HEARTLAB, INC. 510(k) NO: K042042(ABBREVIATED)
ATTN: RICHARD PETROCELLI PHONE NO : 401-596-0592
1 CROSSWIND RD. SE DECISION MADE: 21-SEP-04
WESTERLY, RI 02891 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301
HEARTSINE TECHNOLOGIES, INC. 510(k) NO: K042088(TRADITIONAL)
ATTN: WILLIAM J SMIRLES PHONE NO : 847-317-0926
940 CALLE AMANECER, SUITE E SE DECISION MADE: 02-SEP-04
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSLUX POWER BLUE
HERAEUS KULZER GMBH 510(k) NO: K042199(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6662
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 08-SEP-04
SOUTH BEND, IN 46614-2517 510(k) STATEMENT
DEVICE: SCEPTREP3 PET/CT
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K042428(ABBREVIATED)
ATTN: DOUGLASS THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 17-SEP-04
TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HOVEROUND POWER WHEELCHAIR, MODEL HD700
HOVEROUND CORP. 510(k) NO: K042033(TRADITIONAL)
ATTN: TONY DIGIOVANNI PHONE NO : 941-739-6200
2151 WHITFIELD INDUSTRIAL WAY SE DECISION MADE: 29-SEP-04
SARASOTA, FL 34243 510(k) STATEMENT
DEVICE: SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS
HOWMEDICA OSTEONICS CORP 510(k) NO: K041591(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
325 CORPORATE DR. SE DECISION MADE: 23-SEP-04
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOFFMANN II FOOT RING
HOWMEDICA OSTEONICS CORP. 510(k) NO: K041706(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
325 CORPORATE DRIVE SE DECISION MADE: 08-SEP-04
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUMELOCK II SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K041709(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
325 CORPORATE DRIVE SE DECISION MADE: 09-SEP-04
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K042019(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
325 CORPORATE DRIVE SE DECISION MADE: 24-SEP-04
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA)
HUTCHINSON TECHNOLOGY, INC. 510(k) NO: K042020(TRADITIONAL)
ATTN: THOMAS A DOLD PHONE NO : 320-587-1571
40 WEST HIGHLAND PARK SE DECISION MADE: 15-SEP-04
HUTCHINSON, MN 55350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX
HYGIA HEALTH SERVICES, INC. 510(k) NO: K041867(TRADITIONAL)
ATTN: TRACY WOOD COMAS PHONE NO : 205-314-3920
434 INDUSTRIAL LN. SE DECISION MADE: 10-SEP-04
BIRMINGHAM, AL 35211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SA
IBL GMBH 510(k) NO: K041349(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 570-620-0198
150 CHERRY LANE RD. SE DECISION MADE: 24-SEP-04
EAST STROUDSBURG, PA 18301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UBIPACS
ICM CO., LTD. 510(k) NO: K042507(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 27-SEP-04
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432
ICU MEDICAL, INC. 510(k) NO: K042182(SPECIAL)
ATTN: DALE FAIRCHILD PHONE NO : 800-824-7890
951 CALLE AMANECER SE DECISION MADE: 01-SEP-04
SAN CLEMENTE, CA 92673 510(k) STATEMENT
DEVICE: XPLORER 1600
IMAGING DYNAMICS COMPANY LIMITED 510(k) NO: K042041(TRADITIONAL)
ATTN: ROBIN WINSOR PHONE NO : 403 251 9939
151,2340 PEGASUS WAY NE SE DECISION MADE: 17-SEP-04
CALGARY, CANADA T3G3X5 510(k) STATEMENT
DEVICE: TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ
IMPLEX CORP. 510(k) NO: K040630(TRADITIONAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 30-SEP-04
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MDI ORTHO
IMTEC CORP. 510(k) NO: K042289(TRADITIONAL)
ATTN: J. BRAD VANCE PHONE NO : 580-223-4456
2401 NORTH COMMERCE SE DECISION MADE: 15-SEP-04
ARDMORE, OK 73401 510(k) STATEMENT
DEVICE: ASPIRATION PUMP, MODEL IMD-020
INDUSTRIAL & MEDICAL DESIGN, INC. 510(k) NO: K041405(TRADITIONAL)
ATTN: YEVGENIY KUKLIN PHONE NO : 818-225-8057
2570 CORPORATE PL., SUITE E104 SE DECISION MADE: 02-SEP-04
MONTEREY PARK, CA 91754 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED
INNOLATEX SDN. BHD 510(k) NO: K041837(ABBREVIATED)
ATTN: ELI J CARTER PHONE NO : 919-544-4098
1219 LITTLE CREEK ROAD SE DECISION MADE: 24-SEP-04
DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK,
INOVEL LLC 510(k) NO: K042267(TRADITIONAL)
ATTN: WILLIAM WAWRZYNIAK PHONE NO : 866-546-6835
10111 W. JEFFERSON BLVD. SE DECISION MADE: 30-SEP-04
CULVER CITY, CA 90232-3509 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ULTRACLIP II US
INRAD 510(k) NO: K042341(SPECIAL)
ATTN: MELISSA LALOMIA PHONE NO : 616-301-7800
4375 DONKER COURT S.E. SE DECISION MADE: 20-SEP-04
KENTWOOD, MI 49512 510(k) STATEMENT
DEVICE: HEMOSIL CALIBRATION PLASMA
INSTRUMENTATION LABORATORY CO. 510(k) NO: K041905(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 28-SEP-04
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOW FLOW OSV II HYDROCEPHALUS VALVE
INTEGRA NEUROSCIENCES IMPLANTS S.A510(k) NO: K042192(SPECIAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311
311 ENTERPRISE DRIVE SE DECISION MADE: 02-SEP-04
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM
INTEGRA NEUROSCIENCES, LTD. 510(k) NO: K042277(TRADITIONAL)
ATTN: NIKKI HINTON PHONE NO : 440 126 4345734
NEWBURY RD. SE DECISION MADE: 29-SEP-04
ANDOVER HAMPSHIRE, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M
INVIVO RESEARCH, INC. 510(k) NO: K040915(TRADITIONAL)
ATTN: NEIL BATTISTE PHONE NO : 800-331-3220
12601 RESEARCH PKWY. SE DECISION MADE: 22-SEP-04
ORLANDO, FL 32826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRIS MEDICAL IQ 810 PHOTOCOAGULATOR
IRIDEX CORP. 510(k) NO: K040209(TRADITIONAL)
ATTN: JOHN JOSSY PHONE NO : 650-962-8848
1212 TERRA BELLA AVE. SE DECISION MADE: 20-SEP-04
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARILITE LASER SYSTEM
IRIDEX CORPORATION 510(k) NO: K041930(ABBREVIATED)
ATTN: JOHN JOSSY PHONE NO : 650-940-4700
1212 TERRA BELLA AVENUE SE DECISION MADE: 10-SEP-04
MOUNTAIN VIEW, CA 94043-1824 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ASPIREX - BONE MARROW ASPIRATE KIT
ISOTIS ORTHOBIOLOGICS, INC 510(k) NO: K041991(ABBREVIATED)
ATTN: PAUL DONER PHONE NO : 949-855-7186
2 GOODYEAR, SUITE B SE DECISION MADE: 16-SEP-04
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AZ ULTRASONIC SYSTEM
J. MORITA USA, INC. 510(k) NO: K042056(TRADITIONAL)
ATTN: HOWARD ROWE PHONE NO : 949-465-1034
9 MASON SE DECISION MADE: 30-SEP-04
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER
KENDALL 510(k) NO: K041914(TRADITIONAL)
ATTN: JIM WELSH PHONE NO : 508-261-8532
15 HAMPSHIRE ST. SE DECISION MADE: 27-SEP-04
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOBLANKET
KENSEY NASH CORP. 510(k) NO: K041923(TRADITIONAL)
ATTN: DEBORAH RACIOPPI PHONE NO : 610-524-0188
55 EAST UWCHLAN AVE. SE DECISION MADE: 08-SEP-04
EXTON, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KUNG SHIN, HMEF SK203
KUNG SHIN PLASTICS CO., LTD. 510(k) NO: K032878(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO.58 FU-CHIUN ST SE DECISION MADE: 20-SEP-04
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT
DEVICE: CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE
LAKE REGION MFG., INC. 510(k) NO: K042338(SPECIAL)
ATTN: KAREN MORTENSEN PHONE NO : 952-448-5111
340 LAKE HAZELTINE DR. SE DECISION MADE: 16-SEP-04
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES
LAMONT MEDICAL INC 510(k) NO: K042364(SPECIAL)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 30-SEP-04
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21
LEONHARD LANG GMBH 510(k) NO: K041883(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 07-SEP-04
STILLWATER, MN 55082-0560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LSC LIFESTAND COMPACT
LIFESTAND 510(k) NO: K041535(TRADITIONAL)
ATTN: CAROLANN KOTULA PHONE NO : 770-985-8203
55 NORTHERN BLVD.; SUITE 200 SE DECISION MADE: 16-SEP-04
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-
LIGHT AGE, INC. 510(k) NO: K032991(TRADITIONAL)
ATTN: THOMAS C HAUCK PHONE NO : 732-563-0600
500 APGAR DRIVE SE DECISION MADE: 14-SEP-04
SOMERSET, NJ 08873-1150 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 23
LINVATEC BIOMATERIALS, LTD. 510(k) NO: K042295(SPECIAL)
ATTN: TUIJA ANNALA PHONE NO : 358 3 3165600
HERMIANKATU 6-8L SE DECISION MADE: 16-SEP-04
TAMPERE, FINLAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACROPORE PURICEL LIPOPLASTY SYSTEM
MACROPORE BIOSURGERY, INC. 510(k) NO: K042261(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900
6740 TOP GUN ST. SE DECISION MADE: 20-SEP-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALLARD MODEL 3000 ANESTHESIA MACHINE
MALLARD MEDICAL, INC. 510(k) NO: K033026(TRADITIONAL)
ATTN: ROBERT M PEARSON PHONE NO : 530-226-0727
20268 SKYPARK DR. SE DECISION MADE: 03-SEP-04
REDDING, CA 96002 510(k) STATEMENT
DEVICE: MANTRA TENS MODEL NT3
MANTRA INTL. (HK) LTD. 510(k) NO: K041520(TRADITIONAL)
ATTN: ROBERT B SPERTELL PHONE NO : 818-943-5110
10235 GLADE AVE. SE DECISION MADE: 03-SEP-04
CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANTRA ELECTRODE
MANTRA INTL. (HK) LTD. 510(k) NO: K041902(TRADITIONAL)
ATTN: ROBERT B SPERTELL PHONE NO : 818-943-5110
10235 GLADE AVE. SE DECISION MADE: 22-SEP-04
CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LNCS OXIMETRY SENSORS
MASIMO CORPORATION 510(k) NO: K042346(SPECIAL)
ATTN: JAMES J CRONIN PHONE NO : 949-297-7218
40 PARKER SE DECISION MADE: 20-SEP-04
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATHFINDER
MASSIE RESEARCH LABORATORIES, INC.510(k) NO: K031788(TRADITIONAL)
ATTN: N.A. (BERT) MASSIE PHONE NO : 925-463-7984
5775 W. LOS POSITAS SE DECISION MADE: 02-SEP-04
SUITE 200 510(k) STATEMENT
PLEASANTON, CA 94588-4084
DEVICE: COMPASS M10 SYSTEM
MEDCARE FLAGA 510(k) NO: K041724(TRADITIONAL)
ATTN: BERGLIND HALLGRIMSDOTTIR PHONE NO : 011 354 5102000
SIDUMULI 24 SE DECISION MADE: 28-SEP-04
REYKJAVIK, ICELAND 108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPASS F10 SYSTEM
MEDCARE FLAGA 510(k) NO: K041904(TRADITIONAL)
ATTN: BERGLIND HALLGRIMSDOTTIR PHONE NO : 011 354 5102000
SIDUMULI 24 SE DECISION MADE: 07-SEP-04
REYKJAVIK, ICELAND 108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDCOMP T-3
MEDCOMP 510(k) NO: K033570(TRADITIONAL)
ATTN: JEAN CALLOW PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 16-SEP-04
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADH
MEDIAID INC. 510(k) NO: K041964(TRADITIONAL)
ATTN: KRISTA OAKES PHONE NO : 972-849-5167
2300 MCDERMOTT RD SE DECISION MADE: 14-SEP-04
# 200-207 510(k) SUMMARY AVAILABLE FROM FDA
PLANO, TX 75025
DEVICE: V-CORE FULL CORE BREAST BIOPSY INSTRUMENT
MEDICAL DEVICE TECHNOLOGIES, INC. 510(k) NO: K042464(TRADITIONAL)
ATTN: NICOHL WILDING PHONE NO : 800-424-6779
241 W. PALATINE ROAD SE DECISION MADE: 30-SEP-04
WHEELING, IL 60090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PACSPARTNER
MEDICAL STANDARD CO., LTD. 510(k) NO: K042311(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1100 LAKEVIEW BLVD. SE DECISION MADE: 09-SEP-04
DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LITEPORT LP100 SURGICAL ILLUMINATOR
MEDICAL VISION INDUSTRIES, INC. 510(k) NO: K041621(TRADITIONAL)
ATTN: DAVID SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE STE. C-100 SE DECISION MADE: 13-SEP-04
PLEASANT HILL, CA 94523-3389 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PS MEDICAL NEUROSURGICAL IMPLANTS
MEDTRONIC NEUROSURGERY 510(k) NO: K042198(SPECIAL)
ATTN: JEFFREY HENDERSON PHONE NO : 805-968-1546
125 CREMONA DR. SE DECISION MADE: 24-SEP-04
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGELLAN RATIO DISPENSER KIT
MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K041830(TRADITIONAL)
ATTN: BRUCE BACKLUND PHONE NO : 763-391-9000
7611 NORTHLAND DR. SE DECISION MADE: 29-SEP-04
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K041777(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 03-SEP-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K041862(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 15-SEP-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K042167(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 08-SEP-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORION ANTERIOR CERVICAL PLATING SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K042235(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 17-SEP-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
MEDTRONIC XOMED, INC. 510(k) NO: K041381(TRADITIONAL)
ATTN: DAVID S DODD PHONE NO : 904-332-8746
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 10-SEP-04
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DETECT SURGICAL PACING AND MAPPING TOOL
MEDTRONIC, INC. 510(k) NO: K040812(TRADITIONAL)
ATTN: EDWARD VALDEZ PHONE NO : 763-391-9251
7601 NORTHLAND DR. SE DECISION MADE: 02-SEP-04
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 6416 TEMPORARY PACING LEAD SYSTEM
MEDTRONIC, INC. 510(k) NO: K042190(SPECIAL)
ATTN: PAULA CORDERO PHONE NO : 763-514-8233
7000 CENTRAL AVE. N.E. SE DECISION MADE: 07-SEP-04
MAIL STOP T-202 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55432-3576
DEVICE: ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY
MEDTRONIC, INC. 510(k) NO: K042194(TRADITIONAL)
ATTN: LYNN JENSEN PHONE NO :
7000 CENTRAL AVENUE NE SE DECISION MADE: 15-SEP-04
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3F
MESURE TECHNOLOGY CO.,LTD. 510(k) NO: K042013(SPECIAL)
ATTN: JOHN CHEN PHONE NO : 886 285 122747
7F, 88, SEC. 1, KWANG FU ROAD SE DECISION MADE: 08-SEP-04
SAN CHUNG CITY 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI HSIEN, CHINA (TAIWAN) R.O.C.
DEVICE: ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE M
MICRO THERAPEUTICS, INC. 510(k) NO: K042187(SPECIAL)
ATTN: MARILYN R POURAZAR PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 02-SEP-04
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MHLX7EC TRANSDUCER
MICROHELIX, INC. 510(k) NO: K040213(TRADITIONAL)
ATTN: CHARLES HOTTINGER PHONE NO : 206-780-7945
13221 NE TEEM LOOP ROAD SE DECISION MADE: 22-SEP-04
BAINBRIDGE ISLAND, WA 98110 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: THE STRIPPER PGD
MID-ATLANTIC DIAGNOSTICS, INC. 510(k) NO: K041435(TRADITIONAL)
ATTN: SUSAN J BUSH PHONE NO : 856-762-2000
438 NORTH ELMWOOD RD. SE DECISION MADE: 29-SEP-04
MARLTON, NJ 08053 510(k) STATEMENT
DEVICE: MICROSCOPE SYSTEM
MIRAS MIRROR IMAGING SOLUTIONS, LT510(k) NO: K041805(TRADITIONAL)
ATTN: DORIT WINITZ PH.D. PHONE NO : 972 361 23281
11 MENACHEM BEGIN STREET SE DECISION MADE: 21-SEP-04
RAMAT-GAN, ISRAEL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NARCOTREND, MODEL COMPACT 4.0
MT MONITORTECHNIK GMBH & CO. KG 510(k) NO: K033543(TRADITIONAL)
ATTN: FRIEDMUND WIELAND PHONE NO : 49 508 51643
MAIENBAS 27 SE DECISION MADE: 17-SEP-04
BAD BRAMSTEDT, GERMANY D-24576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONORAIL
NATS CORP. 510(k) NO: K040143(TRADITIONAL)
ATTN: RICHARD LANZILLOTTO PHONE NO : 631-744-0059
30 NORTHPORT RD. SE DECISION MADE: 13-SEP-04
SOUND BEACH, NY 11789-1734 510(k) STATEMENT
DEVICE: EN-BLOC BIOPSY SYSTEM MODEL#777-110,777-001,777-002,777-006,777-
NEOTHERMIA CORPORATION 510(k) NO: K042170(SPECIAL)
ATTN: SHERRIE COVAL-GOLDSMITH PHONE NO : 508-655-7820
ONE APPLE HILL SUITE 316 SE DECISION MADE: 07-SEP-04
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALCAMEA PLATE
NEWDEAL S.A. 510(k) NO: K041786(TRADITIONAL)
ATTN: NORMA F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DR. SE DECISION MADE: 08-SEP-04
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER
NEWPORT MEDICAL INSTRUMENTS, INC. 510(k) NO: K041082(TRADITIONAL)
ATTN: RICHARD WATERS PHONE NO : 949-642-3910
760 WEST 16TH ST., BLDG. N SE DECISION MADE: 07-SEP-04
COSTA MESA, CA 92627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALL SAFE HUBER SAFETY INFUSION SETS
NEXUS MEDICAL, LLC 510(k) NO: K041844(TRADITIONAL)
ATTN: AL BOEDEKER PHONE NO : 913-451-2234
11315 STRANG LINE ROAD SE DECISION MADE: 03-SEP-04
LENEXA, KS 66215 510(k) STATEMENT
DEVICE: NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L
NIPRO MEDICAL CORP. 510(k) NO: K041779(TRADITIONAL)
ATTN: KAELYN B HADLEY PHONE NO : 859-224-8256
1384 COPPERFIELD COURT SE DECISION MADE: 21-SEP-04
LEXINGTON, KY 40514-1268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPRESSION ANASTOMOSIS CLIP (CAC)
NITI MEDICAL TECHNOLOGIES LTD. 510(k) NO: K041751(TRADITIONAL)
ATTN: ORLY MAOR PHONE NO : 972 9 8650610
1 HATZORAN ST. SE DECISION MADE: 16-SEP-04
P.O. BOX 8634 510(k) SUMMARY AVAILABLE FROM FDA
NETANYA, ISRAEL 42506
DEVICE: ZOE FLUID STATUS MONITOR
NONINVASIVE MEDICAL TECHNOLOGIES, 510(k) NO: K042113(SPECIAL)
ATTN: ALDEN KAY PHONE NO : 760-434-5296
4367 TUOLUMNE PLACE SE DECISION MADE: 14-SEP-04
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLO-ASSISTANT
NORTHGATE TECHNOLOGIES, INC. 510(k) NO: K041560(TRADITIONAL)
ATTN: CASEY KUREK PHONE NO : 847-608-8900
600 CHURCH RD. SE DECISION MADE: 28-SEP-04
ELGIN, IL 60123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORALIEF THERAPY FOR SENSITIVE TEETH
NOVAMIN TECHNOLOGY, INC. 510(k) NO: K040858(TRADITIONAL)
ATTN: DAVID C GREENSPAN PHONE NO : 386-418-1551
13709 PROGRESS BLVD., BOX #23 SE DECISION MADE: 02-SEP-04
ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2
OMNISONICS MEDICAL TECHNOLOGIES 510(k) NO: K041705(TRADITIONAL)
ATTN: ANNE M KULIS PHONE NO : 978-657-9980
66 CONCORD STREET, SUITE A SE DECISION MADE: 01-SEP-04
WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, DT-
ORIENTAL SYSTEM TECHNOLOGY, INC. 510(k) NO: K042202(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD. SE DECISION MADE: 10-SEP-04
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101
ORION DIAGNOSTICA OY 510(k) NO: K042442(SPECIAL)
ATTN: ANNIKKA RANTAMA PHONE NO : 358 10 4292736
KOIVU MANKKAAN TIE 6 SE DECISION MADE: 24-SEP-04
ESPOO, FINLAND 02200 510(k) STATEMENT
DEVICE: THE VITROS 5,1 FS CHEMISTRY SYSTEM
ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K041764(TRADITIONAL)
ATTN: CAREY A MAYO PHONE NO : 585-453-3482
100 INDIGO CREEK DR. SE DECISION MADE: 09-SEP-04
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K042303(TRADITIONAL)
ATTN: SARAH GLOVER PHONE NO : 585-453-3154
100 INDIGO CREEK DR. SE DECISION MADE: 27-SEP-04
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K041863(TRADITIONAL)
ATTN: MARLENE A HANNA PHONE NO : 505-453-4041
100 INDIGO CREEK DR. SE DECISION MADE: 20-SEP-04
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHO-PRO CANNULATED BONE SCREWS
ORTHO-PRO LLC 510(k) NO: K042310(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 16-SEP-04
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OUTOLOGOUS SPINAL FIXATION SYSTEM
ORTHOPEDIC SCIENCES, INC 510(k) NO: K040493(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON RD. SE DECISION MADE: 03-SEP-04
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRANIAL HELMET
OTTO BOCK HEALTH CARE, LP 510(k) NO: K041215(TRADITIONAL)
ATTN: SHELLEY STOCKMAN PHONE NO : 763-489-5153
2 CARLSON PWY. STE. 100 SE DECISION MADE: 09-SEP-04
MINNEAPOLIS, MN 55447-4467 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSOMNIA-V3
OXFORD BIOSIGNALS LIMITED 510(k) NO: K042309(TRADITIONAL)
ATTN: SIMON J GRIFFIN PHONE NO : 618-667-6445
611 RIGGIN ROAD SE DECISION MADE: 08-SEP-04
TROY, IL 62294 510(k) STATEMENT
DEVICE: DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
OXOID, LTD. 510(k) NO: K042157(TRADITIONAL)
ATTN: ANDY HOLLINGSWORTH PHONE NO : 44 125 6841144
WADE RD. SE DECISION MADE: 14-SEP-04
BASINGSTOKE, HANTS, UNITED KINGDOM510(k) STATEMENT
DEVICE: PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD
PAJUNK GMBH 510(k) NO: K040965(TRADITIONAL)
ATTN: LYNETTE HOWARD PHONE NO : 908-788-4580
203 MAIN STREET, PMB 166 SE DECISION MADE: 07-SEP-04
FLEMINGTON,, NJ 08822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ HUBER SAFETY INFUSION SET
PFM MEDICAL, INC 510(k) NO: K040533(TRADITIONAL)
ATTN: SALVADORE F PALOMARES PHONE NO : 949-463-6146
2620 TEMPLE HEIGHTS DR. SE DECISION MADE: 17-SEP-04
OCEANSIDE, CA 92056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKSCREEN, MODELS 9177X AND 9178X
PHAMATECH 510(k) NO: K041578(SPECIAL)
ATTN: CARL MONGIOVI PHONE NO : 858-643-5555
10151 BARNES CANYON ROAD SE DECISION MADE: 10-SEP-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A
PHILIPS MEDICAL SYSTEMS 510(k) NO: K040904(TRADITIONAL)
ATTN: TERESA SKARR PHONE NO : 206-664-5290
2301 5TH AVENUE, SUITE 200 SE DECISION MADE: 16-SEP-04
SEATTLE, WA 98121-1825 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLURA 3D-CA, RELEASE 1
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K042334(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 27-SEP-04
P.O. BOX 3003, MS 915 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-3003 THIRD PARTY REVIEW
DEVICE: BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER
PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K042293(TRADITIONAL)
ATTN: ROBERT L TUROCY PHONE NO : 440-483-3528
595 MINER RD. SE DECISION MADE: 08-SEP-04
CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SMARTINFUSER PAINPUMP
PRECISE MEDICAL PRODUCTS 510(k) NO: K042122(TRADITIONAL)
ATTN: OFER SHAI PHONE NO : 972 498 09193
DORA ST. (INDUSTRIAL AREA) SE DECISION MADE: 22-SEP-04
SHLOMI, ISRAEL 22832 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT
PREMIER DENTAL PRODUCTS CO. 510(k) NO: K042215(TRADITIONAL)
ATTN: VINCE D'ALESSANDRO PHONE NO : 610-239-6000
1710 ROMANO DR. SE DECISION MADE: 21-SEP-04
PLYMOUTH MEETING, PA 19462 510(k) STATEMENT
DEVICE: SYNERGY ULTIMATE
PRIDE MOBILITY PRODUCTS CORP. 510(k) NO: K041346(TRADITIONAL)
ATTN: THOMAS J SCHAPPERT PHONE NO : 570-655-5574
182 SUSQUEHANNA AVE. SE DECISION MADE: 08-SEP-04
EXETER, PA 18643 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERSONAL LUBRICATING GEL
QUALIS, INC. 510(k) NO: K041129(TRADITIONAL)
ATTN: MIKE PETERSON PHONE NO : 515-243-3000
4600 PARK AVE. SE DECISION MADE: 24-SEP-04
DES MOINES, IA 50321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260
QUEST MEDICAL, INC. 510(k) NO: K041979(SPECIAL)
ATTN: JANE ANN MARTIN PHONE NO : 972-390-9800
ONE ALLENTOWN PKWY. SE DECISION MADE: 02-SEP-04
ALLEN, TX 75002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R&D; CBC-XE HEMATOLOGY CONTROL
R & D SYSTEMS, INC. 510(k) NO: K042094(SPECIAL)
ATTN: RALPH E HOGANCAMP PHONE NO : 612-656-4413
614 MCKINLEY PL., N.E. SE DECISION MADE: 01-SEP-04
MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES
RADIANT INNOVATION, INC. 510(k) NO: K040377(SPECIAL)
ATTN: FRANK LIN PHONE NO : 886 3 6111666
1F,NO. 3,INDUSTRIAL E. 9TH RD SE DECISION MADE: 16-SEP-04
SCIENCE-BASED INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
HSINCHU, CHINA (TAIWAN) 300
DEVICE: RANDOX TRI LEVEL CARDIAC CONTROL
RANDOX LABORATORIES LIMITED 510(k) NO: K041361(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 442 894 4422413
55 DIAMOND ROAD CRUMLIN SE DECISION MADE: 09-SEP-04
CO ANTRIM 510(k) STATEMENT
CRUMLIN, UNITED KINGDOM BT29 4QY
DEVICE: RAVEN PROTEST - EO
RAVEN BIOLOGICAL LABORATORIES, INC510(k) NO: K041784(TRADITIONAL)
ATTN: WENDY ROYALTY-HANN PHONE NO : 402-593-0781
8607 PARK DR. SE DECISION MADE: 13-SEP-04
OMAHA, NE 68127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS
ROCHE DIAGNOSTICS CORP. 510(k) NO: K033491(TRADITIONAL)
ATTN: JENNIFER TRIBBETT PHONE NO : 800-428-5074
9115 HAGUE RD. SE DECISION MADE: 01-SEP-04
INDIANAPOLIS, IN 46256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL
ROCHE DIAGNOSTICS CORP. 510(k) NO: K042389(SPECIAL)
ATTN: THERESA M AMBROSE PHONE NO : 317-521-3723
9115 HAGUE RD. SE DECISION MADE: 14-SEP-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS FOLATE II CALSET II
ROCHE DIAGNOSTICS CORP. 510(k) NO: K042490(SPECIAL)
ATTN: KAY A TAYLOR MT (ASCP), RAC PHONE NO : 317-521-3544
9115 HAGUE RD. SE DECISION MADE: 30-SEP-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOLTER PLUS
ROZINN ELECTRONICS, INC. 510(k) NO: K042463(TRADITIONAL)
ATTN: MARK ROSOFF PHONE NO : 718-386-5526
71-22 MYRTLE AVE. SE DECISION MADE: 22-SEP-04
GLENDALE, NY 11385 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SAFE T RETRACTABLE BLOOD COLLECTION DEVICE
SAFE T MEDICAL DEVICES, LTD. 510(k) NO: K041941(TRADITIONAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-259-7374
PO BOX 1070 SE DECISION MADE: 13-SEP-04
CONWAY, NH 03818-1070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM
SANARUS MEDICAL, INC. 510(k) NO: K042136(SPECIAL)
ATTN: TRENA DEPEL PHONE NO : 925-460-6080
5880 WEST LAS POSITAS,SUITE 52 SE DECISION MADE: 08-SEP-04
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCANDIUS ACL RECONSTRUCTION SYSTEM
SCANDIUS BIOMEDICAL, INC. 510(k) NO: K041749(TRADITIONAL)
ATTN: ERIC BANNON PHONE NO : 978-486-4088
11A BEAVER BROOK ROAD SE DECISION MADE: 08-SEP-04
LITTLETON, MA 01460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERVICAL PLATE
SCIENT'X 510(k) NO: K042317(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 24-SEP-04
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES
SEAL POLYMER INDUSTRIES BHD. 510(k) NO: K042238(TRADITIONAL)
ATTN: CHUN CHOOI FONG PHONE NO : 605 322 3200
LOT 72706,JALAN LAHAT, KAWASAN SE DECISION MADE: 16-SEP-04
PERINDUSTRIAN BUKIT MERAH 510(k) SUMMARY AVAILABLE FROM FDA
LAHAT, IPOH, PERAK, MALAYSIA 31500
DEVICE: DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D
SEDECAL USA, INC. 510(k) NO: K042361(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 29-SEP-04
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10
SEQUAL TECHNOLOGIES, INC. 510(k) NO: K042262(SPECIAL)
ATTN: BRIAN JARRELL PHONE NO : 858-202-3100
11436 SORRENTO VALLEY RD. SE DECISION MADE: 10-SEP-04
SAN DIEGO, CA 92121-1393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES
SHANDONG PERFECT PLASTIC CO., LTD.510(k) NO: K042213(TRADITIONAL)
ATTN: ALAN P SCHWARTZ PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 09-SEP-04
SUITE 200 510(k) STATEMENT
GREAT NECK, NY 11021
DEVICE: POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES
SHANDONG PERFECT PLASTIC CO., LTD.510(k) NO: K042214(TRADITIONAL)
ATTN: ALAN P SCHWARTZ PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 15-SEP-04
SUITE 200 510(k) STATEMENT
GREAT NECK, NY 11021
DEVICE: DISPOSABLE MONITORING ELECTRODES
SHANGHAI INTCO ELECTRODE MANUFACTU510(k) NO: K041954(TRADITIONAL)
ATTN: CHRIS HEALY PHONE NO : 208-263-5071
500 AIRPORT WAY SE DECISION MADE: 15-SEP-04
SANDPOINT, ID 83864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC (BLUE) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE
SHIJIAZHUANG HONGXIANG PLASTICS PR510(k) NO: K042247(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 714-990-6888
590 W. CENTRAL AVENUE SE DECISION MADE: 02-SEP-04
# D 510(k) SUMMARY AVAILABLE FROM FDA
BREA, CA 92821
DEVICE: NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE
SHIJIAZHUANG TILLOTSON RUBBER PROD510(k) NO: K042378(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 714-990-6888
590 W. CENTRAL AVENUE SE DECISION MADE: 20-SEP-04
SUITE D 510(k) SUMMARY AVAILABLE FROM FDA
BREA, CA 92821
DEVICE: SHINMED MODE SW-988 UNTRASONIC NEBULIZER
SHINING WORLD HEALTH CARE CO., LTD510(k) NO: K031370(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 614-451-1918
NO. 58, FU-CHIUN ST. SE DECISION MADE: 01-SEP-04
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT
DEVICE: M.L. PRIMER
SHOFU DENTAL CORP. 510(k) NO: K040079(TRADITIONAL)
ATTN: DAVID P MORAIS PHONE NO : 760-346-3277
1225 STONE DR. SE DECISION MADE: 09-SEP-04
SAN MARCOS, CA 92069-4059 510(k) STATEMENT
DEVICE: SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE
SIEMENS MEDICAL SOLUTION, INC. USA510(k) NO: K042229(TRADITIONAL)
ATTN: NEALIE HARTMAN PHONE NO : 610-448-1769
51 VALLEY STREAM PKWY. E50 SE DECISION MADE: 01-SEP-04
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEONARDO SYNGO CARDIOLOGY WORKSTATION
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K042203(TRADITIONAL)
ATTN: ANA LADINO PHONE NO : 610-448-1785
51 VALLEY STREAM PKWY. SE DECISION MADE: 24-SEP-04
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM SPIRIT
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K042328(TRADITIONAL)
ATTN: NEALIE HARTMAN PHONE NO : 610-448-1769
51 VALLEY STREAM PARKWAY SE DECISION MADE: 14-SEP-04
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X
SINTEA BIOTECH, INC. 510(k) NO: K041989(TRADITIONAL)
ATTN: ISABELLA ELIAS PHONE NO : 305-673-6226
407 LINCOLN RD. SUITE 10L SE DECISION MADE: 16-SEP-04
MIAMI BEACH, FL 33139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALLOS CMF BONE VOID FILLER
SKELETAL KINETICS, LLC 510(k) NO: K042072(TRADITIONAL)
ATTN: DURAN YETKINLER PHONE NO : 408-366-5000
10201 BUBB RD. SE DECISION MADE: 16-SEP-04
CUPERTINO, CA 95014-4167 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICA
SMITH & NEPHEW, INC. 510(k) NO: K033341(SPECIAL)
ATTN: JANET JOHNSON AKIL PHONE NO : 901-399-5153
1450 E. BROOKS RD. SE DECISION MADE: 10-SEP-04
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE
SMITH & NEPHEW, INC. 510(k) NO: K042312(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 E. BROOKS RD. SE DECISION MADE: 24-SEP-04
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET
SPECIALTY HEALTH PRODUCTS, INC. 510(k) NO: K042234(SPECIAL)
ATTN: MARK NELSON PHONE NO : 801-298-3360
585 WEST 500 SOUTH SE DECISION MADE: 08-SEP-04
BOUNTIFUL, UT 84010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHUNC JUNIOR MODEL# SM 242, CHUNC ADAPT MODEL# SM 251
SPECTRIS TECHNOLOGIES, INC. 510(k) NO: K042304(TRADITIONAL)
ATTN: STEVE GIBSON PHONE NO : 865-609-1411
215 DUNAVANT DRIVE SE DECISION MADE: 08-SEP-04
ROCKFORD, TN 37853 510(k) STATEMENT
DEVICE: PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE
SPO MEDICAL EQUIPMENT LTD. 510(k) NO: K040178(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 976 70002
20 HATA'AS STR; STE 213 SE DECISION MADE: 10-SEP-04
BEIT HAPAMON (BOX 124) 510(k) SUMMARY AVAILABLE FROM FDA
KFAR SABA, ISRAEL 44425
DEVICE: ISITE PACS
STENTOR, INC. 510(k) NO: K042292(TRADITIONAL)
ATTN: DEANA WISEMAN PHONE NO : 650-228-5402
5000 MARINA BLVD. SUITE 100 SE DECISION MADE: 08-SEP-04
BRISBANE, CA 94005-1330 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS
STERILMED, INC. 510(k) NO: K041127(TRADITIONAL)
ATTN: BRUCE LESTER PHONE NO : 888-856-4870
11400 73RD AVE. NORTH SE DECISION MADE: 23-SEP-04
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAUSTED POWERTRAN SERIES STRETCHER
STERIS CORPORATION 510(k) NO: K041924(TRADITIONAL)
ATTN: ROBERT H MCCALL PHONE NO : 334-277-6660
2720 GUNTER PARK DRIVE EAST SE DECISION MADE: 09-SEP-04
MONTGOMERY, AL 36101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERITEC EMU-GRAPH, MODEL NO. CI 131/US
STERITEC PRODUCTS, INC. 510(k) NO: K040901(TRADITIONAL)
ATTN: LINDA NELSON PHONE NO : 303-660-4201
599 TOPEKA WAY, SUITE 400 SE DECISION MADE: 09-SEP-04
CASTLE ROCK, CO 80109 510(k) STATEMENT
DEVICE: STOCKERT SCP RHYTHM
STOCKERT INSTRUMENTE GMBH 510(k) NO: K042374(SPECIAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 23-SEP-04
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER SWITCHPOINT INFINITY
STRYKER COMMUNICATIONS CORP. 510(k) NO: K033132(TRADITIONAL)
ATTN: NATHAN WOODCOCK PHONE NO : 619-401-8400
12140 COMMUNITY ROAD SE DECISION MADE: 02-SEP-04
POWAY, CA 92020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER MAESTRO SYSTEM
STRYKER CORP. 510(k) NO: K041754(TRADITIONAL)
ATTN: NICOLE PETTY PHONE NO : 269-323-7700
4100 E. MILHAM AVE. SE DECISION MADE: 07-SEP-04
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM
STRYKER LEIBINGER 510(k) NO: K041651(TRADITIONAL)
ATTN: WADE T RUTKOSKIE PHONE NO : 269-323-4226
4100 EAST MILHAM AVE. SE DECISION MADE: 30-SEP-04
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLUMBERGEAR(TM), MODEL MULTIPLE (004, 005, 005, 007)
SUITER ENTERPRISES, INC. 510(k) NO: K042294(TRADITIONAL)
ATTN: TIMOTHY J.S. SUITER PHONE NO : 253-833-7418
21230 SE 363RD ST. SE DECISION MADE: 10-SEP-04
AUBURN, WA 98092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FEATHERLIFT EXTENDED LENGTH APTOS THREAD
SURGICAL SPECIALTIES CORP. 510(k) NO: K041593(TRADITIONAL)
ATTN: RICHARD JONES PHONE NO : 610-404-1000
100 DENNIS DR. SE DECISION MADE: 20-SEP-04
READING, PA 19606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STALIF TT
SURGICRAFT LTD. 510(k) NO: K041617(TRADITIONAL)
ATTN: JANET M WEBB PHONE NO : 312-643-1306
121 W. CHESTNUT ST., #3506 SE DECISION MADE: 08-SEP-04
CHICAGO, IL 60610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VACUUM ASSISTED CORE BIOPSY DEVICE
SUROS SURGICAL SYSTEMS, INC. 510(k) NO: K034021(TRADITIONAL)
ATTN: JOSEPH L MARK PHONE NO : 317-334-1040
9502 ANGOLA COURT SUITE 3 SE DECISION MADE: 08-SEP-04
INDIANAPOLIS, IN 46268 510(k) STATEMENT
DEVICE: SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTH
SYNTEX HEALTHCARE PRODUCTS CO. LTD510(k) NO: K042226(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 714 990 6888
590 W. CENTRAL AVENUE, #D SE DECISION MADE: 30-SEP-04
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS
SYNTHES (USA) 510(k) NO: K041533(TRADITIONAL)
ATTN: LISA BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 01-SEP-04
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP
SYNTHES (USA) 510(k) NO: K041611(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 08-SEP-04
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG
SYNTHES (USA) 510(k) NO: K041860(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 08-SEP-04
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) LCP CURVED PLATES
SYNTHES (USA) 510(k) NO: K041911(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 08-SEP-04
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 IN
TAIJECT MEDICAL DEVICE CO., LTD. 510(k) NO: K042426(SPECIAL)
ATTN: JIM-SON CHOU PHONE NO : 949-294-6458
P.O. BOX 8853 SE DECISION MADE: 22-SEP-04
NEWPORT BEACH, CA 92658 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHOT-X II, MODEL 303
TAKARA BELMONT USA, INC. 510(k) NO: K042260(TRADITIONAL)
ATTN: MASAHIRO KANAYA PHONE NO : 800-223-1192
101 BELMONT DR. SE DECISION MADE: 07-SEP-04
SOMERSET, NJ 08873 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: READY-HEAT BLANKET
TECHTRADE LLC 510(k) NO: K042145(TRADITIONAL)
ATTN: ARTHUR M HOROWITZ PHONE NO : 301-468-9252
11900 GAINSBOROUGH ROAD SE DECISION MADE: 17-SEP-04
P.O.BOX 2005 510(k) STATEMENT
POTOMAC, MD 20854-3305
DEVICE: POWER SCOOTER, MODEL TL-688
TEH LIN PROSTHETIC & ORTHOPAEDIC, 510(k) NO: K042010(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 01-SEP-04
HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWER SCOOTER, MODEL TL0821
TEH LIN PROSTHETIC & ORTHOPAEDIC, 510(k) NO: K042011(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 24-SEP-04
HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEH LIN POWER SCOOTER, MODEL TL-822
TEH LIN PROSTHETIC & ORTHOPAEDIC, 510(k) NO: K042012(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 09783
NO. 58, FU-CHIUN ST. SE DECISION MADE: 24-SEP-04
HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE
TELEFLEX MEDICAL 510(k) NO: K042141(TRADITIONAL)
ATTN: STEVE ASTORINO PHONE NO : 508-677-6600
600 AIRPORT RD. SE DECISION MADE: 28-SEP-04
FALL RIVER, MA 02720-4740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE
TERANG NUSA SDN BHD 510(k) NO: K041437(TRADITIONAL)
ATTN: CHIN-GUAN LOW PHONE NO : 609 774 7171
1, JALAN 8, SE DECISION MADE: 16-SEP-04
PENGKALAN CHEPA 2 IND. ZONE 510(k) SUMMARY AVAILABLE FROM FDA
KOTA BHARU, KELANTAN, MALAYSIA 16100
DEVICE: ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC,
THE LAGADO CORP. 510(k) NO: K033599(TRADITIONAL)
ATTN: JOHN M SZABOCSIK PHONE NO : 312-553-0828
203 NORTH WABASH AVENUE SE DECISION MADE: 16-SEP-04
SUITE 1200 510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60601
DEVICE: CORAL SPINAL SYSTEM
THEKEN SURGICAL 510(k) NO: K041592(TRADITIONAL)
ATTN: RANDY THEKEN PHONE NO : 330-773-7677
283 E. WATERLOO ROAD SE DECISION MADE: 16-SEP-04
AKRON, OH 44203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE
TRIAGE MEDICAL, INC. 510(k) NO: K042244(SPECIAL)
ATTN: GAYLE HIROTA PHONE NO : 949-472-0006
13700 ALTON PKWY., SUITE 160 SE DECISION MADE: 16-SEP-04
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIMEDYNE HOLMIUM LASER SYSTEMS
TRIMEDYNE, INC. 510(k) NO: K041660(TRADITIONAL)
ATTN: GLENN YEIK PHONE NO : 949-951-3800
15091 BAKE PKWY. SE DECISION MADE: 08-SEP-04
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COL
TWIN STAR MEDICAL, INC. 510(k) NO: K041771(TRADITIONAL)
ATTN: JONATHAN KAHAN PHONE NO : 202-637-5794
555 13TH STREET NW SE DECISION MADE: 14-SEP-04
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTOGRAM
TYMPANY, INC. 510(k) NO: K041853(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 03-SEP-04
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LTD POLYAXIAL FIXATION SYSTEM
U.S. SPINAL TECHNOLOGIES, LLC. 510(k) NO: K041625(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
PO BOX 560 SE DECISION MADE: 08-SEP-04
STILL WATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER
ULTRASONIX MEDICAL CORPORATION 510(k) NO: K042326(TRADITIONAL)
ATTN: IULIA NUCA PHONE NO : 604 437 9500
310-3480 GILMORE WAY SE DECISION MADE: 16-SEP-04
BURNABY, BRITISH COLUMBIA, CANADA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FACT PLUS ONE-STEP PREGNANCY TEST KIT
UNIPATH LTD. 510(k) NO: K042280(SPECIAL)
ATTN: LOUISE ROBERTS PHONE NO : 44 123 4835564
PRIORY BUSINESS PARK SE DECISION MADE: 10-SEP-04
BEDFORD, UNITED KINGDOM MK44 3UP 510(k) STATEMENT
DEVICE: MODIFIED SPACEMAKER SYSTEM
UNITED STATES SURGICAL, A DIVISION510(k) NO: K042412(SPECIAL)
ATTN: RENEE ALFANO PHONE NO : 203-492-5325
150 GLOVER AVE. SE DECISION MADE: 24-SEP-04
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL
USA INSTRUMENTS, INC. 510(k) NO: K042342(SPECIAL)
ATTN: JAMES WRENN PHONE NO : 330-562-1000
1515 DANNER DR. SE DECISION MADE: 24-SEP-04
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGASURE PRECISE MODEL #LS1200/LIGASURE 5MM LAPAROSCOPIC SEALER
VALLEYLAB 510(k) NO: K041587(TRADITIONAL)
ATTN: CHARLES COPPERBERG PHONE NO : 303-530-6247
5920 LONGBOW DR. SE DECISION MADE: 28-SEP-04
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P4-FITNESS
VALMED CORP. 510(k) NO: K031611(TRADITIONAL)
ATTN: GUY POITOUT PHONE NO : 561-841-2448
5080 NORTH OCEAN DRIVE 1A SE DECISION MADE: 29-SEP-04
SINGER ISLAND, FL 33404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP)
VASCULAR SOLUTIONS, INC. 510(k) NO: K041909(TRADITIONAL)
ATTN: SARA L COON PHONE NO : 763-656-4399
6464 SYCAMORE COURT NORTH SE DECISION MADE: 23-SEP-04
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EPTFE GRAFT
VASCUTEK LTD. 510(k) NO: K041528(TRADITIONAL)
ATTN: STEVEN ARICK PHONE NO : 734-663-4145
6200 JACKSON RD. SE DECISION MADE: 14-SEP-04
ANN ARBOR, MI 48103-9300 510(k) STATEMENT
DEVICE: DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9
VEGA TECHNOLOGIES, INC. 510(k) NO: K041516(TRADITIONAL)
ATTN: JOSEPH LU PHONE NO : 886 225 416996
11F-13, 100 CHANG-CHUN RD. SE DECISION MADE: 08-SEP-04
TAIPEI, CHINA (TAIWAN) 104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREMICATH, 1261.205
VYGON CORP. 510(k) NO: K041468(TRADITIONAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300
2495 GENERAL ARMISTEAD AVE SE DECISION MADE: 09-SEP-04
NORRISTOWN, PA 19403 510(k) STATEMENT
DEVICE: DELFIA NEONATAL 17A-OH-PROGESTERONE KIT
WALLAC OY 510(k) NO: K042424(SPECIAL)
ATTN: GUNNEL LAAKSONEN PHONE NO : 358 2 2678111
MUSTIONKATU 6 SE DECISION MADE: 30-SEP-04
TURKU, FINLAND 20750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
WALLAC OY 510(k) NO: K042425(SPECIAL)
ATTN: GUNNEL LAAKSONEN PHONE NO : 358 2 2678111
MUSTIONKATU 6 SE DECISION MADE: 30-SEP-04
TURKU, FINLAND 20750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARION
WAVELIGHT LASER TECHNOLOGIE AG 510(k) NO: K042474(TRADITIONAL)
ATTN: THORSTEN CRETER PHONE NO : 490 610 23690
FRANKFURTER STRASSE 229 SE DECISION MADE: 29-SEP-04
NEU-ISENBURG, GERMANY D-63263 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20
WELCH ALLYN, INC. 510(k) NO: K040479(TRADITIONAL)
ATTN: DAVID KLEMENTOWSKI PHONE NO : 315-685-4133
4341 STATE ST. RD. SE DECISION MADE: 14-SEP-04
SKANEATELES FALLS, NY 13153-0220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PL
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K041663(TRADITIONAL)
ATTN: BRIAN J YOUNG PHONE NO : 901-867-4457
5677 AIRLINE RD. SE DECISION MADE: 16-SEP-04
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONE FUSION PLATE SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K042205(TRADITIONAL)
ATTN: JEANINE H REDDEN PHONE NO : 901-867-4522
5677 AIRLINE RD. SE DECISION MADE: 20-SEP-04
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC)
ZARGIS MEDICAL CORP. 510(k) NO: K042128(SPECIAL)
ATTN: DONALD BROOKS PHONE NO : 609-734-6552
755 COLLEGE RD. EAST SE DECISION MADE: 08-SEP-04
PRINCETON, NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEWA MFM-007 BLOOD PRESSURE MONITOR
ZEWA, INC. 510(k) NO: K041491(TRADITIONAL)
ATTN: THOMAS ZEINDLER PHONE NO : 305-463-7551
3537 N.W. 115TH AVENUE SE DECISION MADE: 20-SEP-04
MIAMI, FL 33178 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLS SPOTORNO STEM
ZIMMER AUSTIN, INC. 510(k) NO: K042249(SPECIAL)
ATTN: AUDREY SWEARINGEN PHONE NO : 512-432-9255
9900 SPECTRUM DR. SE DECISION MADE: 15-SEP-04
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ST360 SPINAL FIXATION SYSTEM
ZIMMER SPINE, INC. 510(k) NO: K041925(SPECIAL)
ATTN: KRISTIN JANS PHONE NO : 952-830-6273
7375 BUSH LAKE RD. SE DECISION MADE: 24-SEP-04
MINNEAPOLIS, MN 55439-2027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER TRABECULAR METAL HUMERAL STEM
ZIMMER, INC. 510(k) NO: K041549(TRADITIONAL)
ATTN: DALENE BINKLEY PHONE NO : 574-372-4907
P.O. BOX 708 SE DECISION MADE: 01-SEP-04
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 293
TOTAL WITH SUMMARIES 247
TOTAL WITH STATEMENTS 46
Updated October 5, 2004
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