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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K922840
Device Name ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS
Applicant
Gish Biomedical, Inc.
2350 S. Pullman Ave.
Santa Ana,  CA  92705
Applicant Contact BRIAN STRAUSS
Correspondent
Gish Biomedical, Inc.
2350 S. Pullman Ave.
Santa Ana,  CA  92705
Correspondent Contact BRIAN STRAUSS
Regulation Number870.4290
Classification Product Code
DTL  
Date Received06/12/1992
Decision Date 05/17/1993
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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