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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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safepro plus safety syringe FORMOSA MEDICAL DEVICES, INC. k031830 08/05/2003
sa 9900 plus diagnostic ultrasound system MEDISON AMERICA, INC. k032329 08/06/2003
randox liquid protein calibrator RANDOX LABORATORIES, LTD. k031608 08/08/2003
cardiovations portable video system ETHICON, INC. k032339 08/08/2003
mallory/head total hip system; ha mallory/head total hip system; bi-metric femoral components BIOMET, INC. k030055 08/11/2003
cryocare cs surgical system ENDOCARE, INC. k032333 08/12/2003
iur fluid management system W.O.M. WORLD OF MEDICINE AG k031616 08/13/2003
gore introducer sheath with silicone pinch valve W. L. GORE & ASSOCIATES, INC. k032073 08/13/2003
conduction catheter MICOR, INC. k031600 08/13/2003
statco2meter, model 10-55372 MERCURY MEDICAL k031814 08/14/2003

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