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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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hitachi airis ii HITACHI MEDICAL SYSTEMS AMERICA, INC. k001334 07/06/2000
acumatch l-series cemented femoral stem, model l-series cemented EXACTECH, INC. k001335 05/18/2000
dr9000 digital radiography x-ray system ANALOGIC CORP. k001336 06/02/2000
daniels sharpsmart reusable sharps container THE DANIELS CORP. k001337 07/05/2000
microvasive rapid exchange biliary balloon dilatation catheter BOSTON SCIENTIFIC CORP. k001338 08/30/2000
mri fastsystem retractor system OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC. k001339 05/17/2000
stackable cage system DEPUY ACROMED k001340 07/26/2000
captia syphilis-g elisa test system TRINITY BIOTECH, PLC k001525 11/29/2000
fotona fidelis er: yag laser system and accesories FOTONA D.D. k001527 07/27/2000
pc flow + SPIROMETRICS MEDICAL EQUIPMENT CO. k001528 01/18/2001

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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