VAPR ARCTIC SUCTION ELECTRODE

Electrosurgical, Cutting & Coagulation & Accessories

DEPUY MITEK, A JOHNSON & JOHNSON COMPANY

The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Vapr Arctic Suction Electrode.

Pre-market Notification Details

Device IDK140896
510k NumberK140896
Device Name:VAPR ARCTIC SUCTION ELECTRODE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham,  MA  02767
ContactSusan Kagan
CorrespondentSusan Kagan
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-08
Decision Date2014-08-05
Summary:summary

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