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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, biliary, diagnostic
510(k) Number K121430
Models EVO-10-11-X-B, WHERE X CAN BE 4,6,8, OR 10, EVO-8-9-X-B, WHERE X CAN BE 4, 6, 8, OR 10
Device Name EVOLUTION BILIARY STENT SYSTEM
Original Applicant
COOK IRELAND LTD
o halloran road
national technology park
limerick,  IE 000
Original Contact jacinta kilmartin
Regulation Number876.5010
Classification Product Code
FGE  
Date Received05/14/2012
Decision Date 03/01/2013
Decision substantially equivalent - with limitations (SU)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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