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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 K091542
Device Name ESTECH EASYFLOW CANNULA WITH GUIDEWIRE
Applicant
Endoscopic Technologies, Inc. D/B/A Estech
2603 Camino Ramon
Suite 100
San Ramon,  CA  94583
Applicant Contact TAMER IBRAHIM
Correspondent
Endoscopic Technologies, Inc. D/B/A Estech
2603 Camino Ramon
Suite 100
San Ramon,  CA  94583
Correspondent Contact TAMER IBRAHIM
Regulation Number870.4210
Classification Product Code
DWF  
Date Received05/26/2009
Decision Date 10/20/2009
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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