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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Metallic, Expandable, Duodenal
510(k) Number K163468
Device Name Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered
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
MUM  
Subsequent Product Code
MQR  
Date Received12/12/2016
Decision Date 05/04/2017
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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