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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
Applicant
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
600 AIRPORT RD.
FALL RIVER,  MA  02720 -4740
Applicant Contact STEPHEN M PAGE
Correspondent
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
600 AIRPORT RD.
FALL RIVER,  MA  02720 -4740
Correspondent Contact STEPHEN M PAGE
Regulation Number868.5830
Classification Product Code
CAC  
Date Received08/04/1998
Decision Date 12/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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