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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stent, colonic, metalic, expandable
510(k) Number K113510
Model EVO-25-30-6-C, EVO-25-30-8-C, EVO-25-30-10-C
Device Name EVOLUTION COLONIC STENT SYSTEM
Original Applicant
COOK IRELAND LTD
o'halloran road
national technology park
limerick,  EI ei
Original Contact jacinta kilmartin
Regulation Number878.3610
Classification Product Code
MQR  
Date Received11/28/2011
Decision Date 05/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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