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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 K082082
Device Name GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING
Applicant
Gish Biomedical, Inc.
22942 Arroyo Vista
Rancho Santa Margarita,  CA  92688
Applicant Contact MARTIN SELLERS
Correspondent
Gish Biomedical, Inc.
22942 Arroyo Vista
Rancho Santa Margarita,  CA  92688
Correspondent Contact MARTIN SELLERS
Regulation Number870.4400
Classification Product Code
DTN  
Date Received07/23/2008
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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