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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name apparatus, autotransfusion
510(k) Number K982650
Device Name AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)
Original Applicant
DIDECO S.P.A.
49 plain st.
north attleboro,  MA  02760
Original Contact rosina robinson
Regulation Number868.5830
Classification Product Code
CAC  
Date Received07/30/1998
Decision Date 12/16/1998
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Cardiovascular
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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