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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
Number
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Decision
Date
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modification to the maestro system BIOHORIZONS IMPLANT SYSTEMS, INC. k030463 02/26/2003
zephir anterior cervical system MEDTRONIC SOFAMOR DANEK k030327 02/26/2003
senorx es-300 SENORX, INC. k030473 02/26/2003
modification to vitros immundodiagnostic products troponin i reagent pack/calibrators ORTHO-CLINICAL DIAGNOSTICS k024193 02/21/2003
nexus injection site (nis), model nis-1 NEXUS MEDICAL, LLC k024363 02/19/2003
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
samaritan aed, model sam-01 HEARTSINE TECHNOLOGIES, INC. k023854 02/14/2003
guidant syncrus internal cardioversion system GUIDANT CORPORATION, CARDIAC SURGERY k024071 02/14/2003
davol arthrovent outflow tubing DAVOL, INC. k030307 02/13/2003
hemosil factor vii deficient plasma INSTRUMENTATION LABORATORY CO. k024082 02/12/2003

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