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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 K032632
Device Name REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH
Applicant
Estech, Inc.
4135 Blackhawk Plz. Cir.
Suite 150
Danville,  CA  94506
Applicant Contact ARTHUR BERTOLERO
Correspondent
Estech, Inc.
4135 Blackhawk Plz. Cir.
Suite 150
Danville,  CA  94506
Correspondent Contact ARTHUR BERTOLERO
Regulation Number870.4210
Classification Product Code
DWF  
Date Received08/26/2003
Decision Date 10/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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