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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 K121430
Device Name EVOLUTION BILIARY STENT SYSTEM
Applicant
COOK IRELAND LTD
O HALLORAN ROAD
NATIONAL TECHNOLOGY PARK
LIMERICK,  IE 000
Applicant Contact Jacinta Kilmartin
Correspondent
COOK IRELAND LTD
O HALLORAN ROAD
NATIONAL TECHNOLOGY PARK
LIMERICK,  IE 000
Correspondent Contact Jacinta Kilmartin
Regulation Number876.5010
Classification Product Code
FGE  
Date Received05/14/2012
Decision Date 03/01/2013
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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