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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heat-Exchanger, Cardiopulmonary Bypass
510(k) Number K925369
Device Name BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS
Applicant
Sorin Biomedica, Fiat, USA, Inc.
17600 Gilette Ave.
Irvine,  CA  92713
Applicant Contact DONNA FREE
Correspondent
Sorin Biomedica, Fiat, USA, Inc.
17600 Gilette Ave.
Irvine,  CA  92713
Correspondent Contact DONNA FREE
Regulation Number870.4240
Classification Product Code
DTR  
Date Received10/23/1992
Decision Date 03/26/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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