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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 K902759
Device Name COBE CLOSED WOUND DRAINAGE KIT
Original Applicant
COBE LABORATORIES, INC.
14401 west 56th way
arvada,  CO  80004
Original Contact mary l armstrong
Regulation Number868.5830
Classification Product Code
CAC  
Date Received06/25/1990
Decision Date 07/18/1990
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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