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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K961530
Device Name GISH RELIANCE OXYGENATOR (MODEL HFO)
Applicant
Gish Biomedical, Inc.
2681 Kelvin Ave.
Irvine,  CA  92614
Applicant Contact JACK W BROWN
Correspondent
Gish Biomedical, Inc.
2681 Kelvin Ave.
Irvine,  CA  92614
Correspondent Contact JACK W BROWN
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received04/22/1996
Decision Date 12/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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