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510(k)s Final Decisions Rendered for September 2004 |
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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