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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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Decision
Date
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acon quick-check ii home pregnancy test device (cassette) ACON LABORATORIES, INC. k032661 10/14/2003
proven revision femoral and proven revision tibial insert STELKAST COMPANY k031901 10/10/2003
neurolac nerve guide models ng01-15/03, ng01-020/03, ng01 025/03, ng01-030/03 Polyganics BV k032115 10/10/2003
radiodexter version 1.0, dextroscope, model mk10 and dextrobeam, model mk3 VOLUME INTERACTIONS PTE LTD k032924 10/10/2003
novus ttx laser and delivery devices with accessories LUMENIS, INC. k032357 10/09/2003
sonoma anterior cervical plate system SEASPINE k032368 10/09/2003
port cassette OREX COMPUTED RADIOGRAPHY LTD k032654 10/09/2003
betec retractable safety syringe (5ml) BETEC MEDICAL SCIENCE CO., LTD. k031909 10/07/2003
bd phoenix automated microbiology system-ceftriaxone 0.5-64 ug/ml BECTON, DICKINSON & CO. k032655 10/06/2003
disposable powder free vinyl synthetic exam gloves KINGSWELL INTERNATIONAL INC. k032668 10/06/2003

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