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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 K162717
Device Name Evolution Esophageal Stent System – Partially Covered
Applicant
Cook Ireland, Ltd.
O' Halloran Rd., National Technology Park
Limerick,  IE
Applicant Contact Jane Kennedy
Correspondent
Cook Ireland, Ltd.
O' Halloran Rd., National Technology Park
Limerick,  IE
Correspondent Contact Jane Kennedy
Regulation Number878.3610
Classification Product Code
ESW  
Date Received09/29/2016
Decision Date 12/21/2016
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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