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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Esophageal
510(k) Number K093619
Device Name EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E
Applicant
Cook Ireland, Ltd.
O' Halloran Rd., National Technology Park
Limerick,  IE
Applicant Contact Jacinta Kilmartin
Correspondent
Cook Ireland, Ltd.
O' Halloran Rd., National Technology Park
Limerick,  IE
Correspondent Contact Jacinta Kilmartin
Regulation Number878.3610
Classification Product Code
ESW  
Date Received11/23/2009
Decision Date 06/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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