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U.S. Department of Health and Human Services

510(K) Premarket Notification

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echo sounder, single-handed, model es-101ex KOVEN TECHNOLOGY, INC. k031504 07/18/2003
medtronic resting heart system, model aar1000 and 711 MEDTRONIC PERFUSION SYSTEMS k031700 08/29/2003
sapphire detachable fiber coils MICRO THERAPEUTICS, INC. k031852 08/20/2003
fluoride varnish DENTSPLY INTL. k031932 09/15/2003
durex play lubricant SSL AMERICAS, INC. k032124 01/16/2004
bioteque a.v. fistula needle set with safety flex BIOTEQUE CORP. k032292 03/22/2004
dekompressor percutaneous discectomy probe STRYKER INSTRUMENTS k032473 11/07/2003
disposable powder free vinyl synthetic exam gloves with aloe vera green color KINGSWELL INTERNATIONAL INC. k032670 11/14/2003
c. difficile toxin a + b fecal antigen detection microwell elisa kit model; cdiff-96 IVD RESEARCH, INC. k032897 05/27/2004
c-graft THE CLINICIAN'S PREFERENCE LLC k033110 12/10/2003

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