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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K990573
Device Name ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA
Applicant
Estech, Inc.
4115 Blackhawk Plz. Cir.
#100
Danville,  CA  94506
Applicant Contact ARTHUR BERTOLERO
Correspondent
Estech, Inc.
4115 Blackhawk Plz. Cir.
#100
Danville,  CA  94506
Correspondent Contact ARTHUR BERTOLERO
Regulation Number870.4450
Classification Product Code
DXC  
Subsequent Product Code
DWF  
Date Received02/23/1999
Decision Date 03/11/1999
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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