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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 K913773
Device Name COBE BRAT SYSTEMS WITHOUT REINFUSION PROTECTION
Original Applicant
COBE CARDIOVASCULAR, INC.
14401 west 65th way
arvada,  CO  80004
Original Contact mary l armstrong
Regulation Number868.5830
Classification Product Code
CAC  
Date Received08/23/1991
Decision Date 01/27/1992
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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