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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
Date
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depuy summit fx cemented hip prosthesis DEPUY ORTHOPAEDICS, INC. k023453 11/13/2002
electro-nerve stimulator tens model bmls02-10 BIOMEDICAL LIFE SYSTEMS, INC. k022925 11/19/2002
pvs 1600 synchro 0.010 neuro guide wire PRECISION VASCULAR SYSTEMS, INC. k023700 12/04/2002
lidcoplus hemodynamic monitor system, model hm 70 LIDCO LTD. k023960 01/09/2003
liquichek ana control homogeneous pattern control, posotive, catalog #118 BIO-RAD k024221 01/15/2003
oria zenith ORTHOTEC, L.L.C. k030500 03/20/2003
complete brand multi-purpose solution ADVANCED MEDICAL OPTICS, INC. k030092 04/04/2003
freezor xtra surgical cardiac cryoablation device and cct.2 cardiac cardiac cryoablation cryoconsole CRYOCATH TECHNOLOGIES, INC. k030303 04/29/2003
ranfac goldenberg snarecoil soft tissue biopsy (gss) needle RANFAC CORP. k031344 05/23/2003
vinyl exam gloves, powder-free, yellow SHANGHAI JIAWANG INDUSTRIAL CO. LTD. k031854 07/25/2003

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