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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 K052081
Device Name REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA
Applicant
Estech, Inc.
1193 Sherman St.
Alameda,  CA  94501
Applicant Contact CRAIG COOMBS
Correspondent
Estech, Inc.
1193 Sherman St.
Alameda,  CA  94501
Correspondent Contact CRAIG COOMBS
Regulation Number870.4210
Classification Product Code
DWF  
Date Received08/02/2005
Decision Date 12/16/2005
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
Recalls CDRH Recalls
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