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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 K040355
Device Name VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING
Applicant
Gish Biomedical, Inc.
11874 S. Evelyn Circle
Houston,  TX  77071
Applicant Contact J. HARVEY KNAUSS
Correspondent
Gish Biomedical, Inc.
11874 S. Evelyn Circle
Houston,  TX  77071
Correspondent Contact J. HARVEY KNAUSS
Regulation Number870.4240
Classification Product Code
DTR  
Date Received02/12/2004
Decision Date 03/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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