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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscopic injection needle, gastroenterology-urology
510(k) Number K113634
Model IC-607023
Device Name INJEKT CYSTO FLEXIBLE INJECTION NEEDLE
Original Applicant
COOK IRELAND LTD
o'halloran road
national technology park
limerick,  EI el
Original Contact laura guinane
Regulation Number876.1500
Classification Product Code
FBK  
Date Received12/09/2011
Decision Date 02/14/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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