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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 K974897
Device Name COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET
Original Applicant
COBE CARDIOVASCULAR, INC.
14401 west 65th way
arvada,  CO  80004
Original Contact lynne leonard
Regulation Number868.5830
Classification Product Code
CAC  
Date Received12/31/1997
Decision Date 03/31/1998
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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