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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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spife ld vis isoenzyme kit, models 3450, 3451, and 3452 HELENA LABORATORIES k020467 03/29/2002
codan us i.v. administration set, model b400 sp CODAN US CORP. k013714 03/28/2002
emit ii plus monoclonal cocaine metabolite assay DADE BEHRING, INC. k020441 03/28/2002
access sequestration system INTERPORE CROSS INTL. k012406 03/26/2002
moonray mobile c-arm SIMAD S.R.L. k013426 03/26/2002
smith & nephew twinfix ti quick t SMITH & NEPHEW, INC. k020159 03/26/2002
dinamap pro 1000 monitor, model 1000 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES k012915 03/21/2002
diabetes assistant software ROCHE DIAGNOSTICS CORP. k014139 03/21/2002
odi talon intramedullary hip nail ORTHOPEDIC DESIGNS, INC. k014189 03/21/2002
synthes high tibial osteotomy plate SYNTHES (USA) k014197 03/21/2002

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