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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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510(K)
Number
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Decision
Date
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uriscan optima ii urine analyzer YD DIAGNOSTICS k050801 04/20/2005
wagner sl revision stem lateral ZIMMER AUSTIN, INC. k043356 04/18/2005
powder free nitrile examination glove (blue) (this product does not contain thiuram, and/or carbamate and/or thiazole) SMART GLOVE CORP. SDN BHD k050122 04/18/2005
ontrak testcard 9 VARIAN INC k050321 04/18/2005
functional anaesthetic discography (fad) system, including fad catheter kit and fad introducer needle INNOSPINE, INC. k043500 04/15/2005
spirit, model has CAIRE, INC. k050153 04/15/2005
primasolo one-piece implants & healing caps LIFECORE BIOMEDICAL, INC. k050506 04/15/2005
artherx corkscrew ft ii suture anchor ARTHREX, INC. k050358 04/15/2005
thrombigel thrombin/gelatin foam hemostat VASCULAR SOLUTIONS, INC. k050511 04/14/2005
chlorinated powder free latex examination gloves with protein labeling claim (contains 50 micrograms or less of total wa SPI GLOVES SDN. BHD. k050532 04/14/2005

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