COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

COOK IRELAND LTD

The following data is part of a premarket notification filed by Cook Ireland Ltd with the FDA for Cook Ireland Duette Multi-band Mucosectomy Device.

Pre-market Notification Details

Device IDK050578
510k NumberK050578
Device Name:COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant COOK IRELAND LTD O'HOLLORAN ROAD NATIONAL TECHNOLOGICAL PARK Limerick,  IE
ContactEmmett Devereux
CorrespondentEmmett Devereux
COOK IRELAND LTD O'HOLLORAN ROAD NATIONAL TECHNOLOGICAL PARK Limerick,  IE
Product CodeKNS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-07
Decision Date2005-04-22
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.