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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sucker, Cardiotomy Return, Cardiopulmonary Bypass
510(k) Number K053021
Device Name ESTECH CLEARVIEW MV ATRIAL DEPRESSOR
Applicant
ESTECH, INC.
1193 SHERMAN STREET
ALAMEDA,  CA  94501
Applicant Contact CRAIG COOMBS
Correspondent
ESTECH, INC.
1193 SHERMAN STREET
ALAMEDA,  CA  94501
Correspondent Contact CRAIG COOMBS
Regulation Number870.4420
Classification Product Code
DTS  
Date Received10/26/2005
Decision Date 01/26/2006
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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