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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K163018
Device Name Zilver 635 Biliary Stent
Applicant
Cook Ireland Ltd.
O'Halloran Road
National Technology Park
Limerick,  IE
Applicant Contact Nora O'Connor
Correspondent
Cook Ireland Ltd.
O'Halloran Road
National Technology Park
Limerick,  IE
Correspondent Contact Nora O'Connor
Regulation Number876.5010
Classification Product Code
FGE  
Date Received10/31/2016
Decision Date 12/23/2016
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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