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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 K023381
Device Name VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN 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 Number870.4350
Classification Product Code
DTZ  
Date Received10/08/2002
Decision Date 03/31/2003
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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