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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K081881
Device Name GISH TUBING AND CONNECTORS WITH HA COATING
Applicant
Gish Biomedical, Inc.
22942 Arroyo Vista
Rancho Santa Margarita,  CA  92688
Applicant Contact EDWARD F WADDELL
Correspondent
Gish Biomedical, Inc.
22942 Arroyo Vista
Rancho Santa Margarita,  CA  92688
Correspondent Contact EDWARD F WADDELL
Regulation Number870.4210
Classification Product Code
DWF  
Date Received07/02/2008
Decision Date 01/23/2009
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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