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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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propeller head small cannulated screw system BIOMET ORTHOPEDICS, INC. k024086 01/09/2003
urine monovette boric acid SARSTEDT, INC. k024237 04/14/2003
atac pak phosphorus reagent ELAN DIAGNOSTICS k030015 03/07/2003
medtronic minimed sof-site infusion set, models mmt-358s6, mmt-358m6, mmt-358l6, mmt-358s9, mmt-358m9, and mmt-358l9 AVAIL MEDICAL PRODUCTS, INC. k030137 02/19/2003
f1 diode laser system OPUS MEDICAL, INC. k030235 04/23/2003
handydop ELCAT, GMBH k030466 09/12/2003
scope guard protective sheath, model tel-sh ACMI CORPORATION k030684 06/03/2003
rebilda dc VOCO GMBH k030914 05/30/2003
everest lp bipolar scissors and gyrus lp bipolar scissors GYRUS MEDICAL, INC. k031081 05/21/2003
aesculap-miethke shunt system gravity assisted valve (gav) AESCULAP, INC. k031303 06/04/2003

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