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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K081947
Device Name GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
Applicant
Gish Biomedical, Inc.
11874 S. Evelyn Circle
Houston,  TX  77071
Applicant Contact HARVEY KNAUSS
Correspondent
Gish Biomedical, Inc.
11874 S. Evelyn Circle
Houston,  TX  77071
Correspondent Contact HARVEY KNAUSS
Regulation Number870.4400
Classification Product Code
DTN  
Date Received07/08/2008
Decision Date 02/04/2009
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
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