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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
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auto i.d. jo-1, scl-70 & pcna positive control serum IMMUNO CONCEPTS, N.A., LTD k030775 05/12/2003
hi-torque pilot 50 guide wire with hydrocoat hydrophilic coating, hi-torque pilot 150 guide wire with hydrocoat hydrophg GUIDCORP k030549 05/14/2003
codman bactiseal barium striped catheters Codman & Shurtleff, Inc. k031123 05/14/2003
olympic cfm 6000 OLYMPIC MEDICAL CORP. k031149 05/14/2003
alveolus inc., tb-sts tracheobronchial stent system ALVEOLUS, INC. k030947 05/15/2003
hemosil factor x deficient plasma INSTRUMENTATION LABORATORY CO. k031122 05/19/2003
dolphin 2000 pulse oximetry sensors models 2010, 2311 adult, 2312 pediatric, 2313 infant, 2314 neonatal, 2421 DOLPHIN MEDICAL INC. k030952 05/19/2003
callos SKELETAL KINETICS, LLC k030554 05/20/2003
disposable powdered vinyl exam gloves ELITE INTERNATIONAL, INC. k031134 05/20/2003
rfx fluroscopic digital imaging system SIGMA VISION, INC. k030544 05/21/2003

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