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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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modification to fortitude cement restrictor SPINAL CONCEPTS, INC. k031837 07/24/2003
uc-plus solution unicondylar knee PLUS ORTHOPEDICS k032052 07/25/2003
modification to macs modular anterior construct system AESCULAP, INC. k032059 07/25/2003
stellartech coagulation system, models (1100c-115 & 1100c-230) STELLARTECH RESEARCH CORP. k032062 07/29/2003
modification to reprocessed synthes external fixation devices ALLIANCE MEDICAL CORP. k032058 07/30/2003
ucr spinal system, laminar hooks, pedicle hooks, and instruments SEASPINE k031381 07/30/2003
earlydetect menopause test for fsh EARLY DETECT, INC. k030058 07/30/2003
microscan synergies plus gram negative mic/combo panels with nitrofurantoin (1-256 ug/ml) DADE BEHRING, INC. k031602 07/31/2003
hemosil factor ix deficient plasma INSTRUMENTATION LABORATORY CO. k031829 07/31/2003
tina-quant crp (latex) ROCHE DIAGNOSTICS CORP. k032336 08/05/2003

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