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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 K982712
Device Name RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250
Original Applicant
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
600 airport rd.
fall river,  MA  02720 4740
Original Contact stephen m page
Regulation Number868.5830
Classification Product Code
CAC  
Date Received08/04/1998
Decision Date 12/18/1998
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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