PLASMATRODE SALINE SAFE TUR ELECTRODE

Electrosurgical, Cutting & Coagulation & Accessories

COOK IRELAND LTD

The following data is part of a premarket notification filed by Cook Ireland Ltd with the FDA for Plasmatrode Saline Safe Tur Electrode.

Pre-market Notification Details

Device IDK122716
510k NumberK122716
Device Name:PLASMATRODE SALINE SAFE TUR ELECTRODE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant COOK IRELAND LTD O HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick,  IE 000
ContactNora O'connor
CorrespondentNora O'connor
COOK IRELAND LTD O HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick,  IE 000
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-05
Decision Date2013-04-17
Summary:summary

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