INJEKT CYSTO FLEXIBLE INJECTION NEEDLE

Endoscopic Injection Needle, Gastroenterology-urology

COOK IRELAND LTD

The following data is part of a premarket notification filed by Cook Ireland Ltd with the FDA for Injekt Cysto Flexible Injection Needle.

Pre-market Notification Details

Device IDK113634
510k NumberK113634
Device Name:INJEKT CYSTO FLEXIBLE INJECTION NEEDLE
ClassificationEndoscopic Injection Needle, Gastroenterology-urology
Applicant COOK IRELAND LTD O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick,  IE El
ContactLaura Guinane
CorrespondentLaura Guinane
COOK IRELAND LTD O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick,  IE El
Product CodeFBK  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-09
Decision Date2012-02-14
Summary:summary

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