MicroFrance Monopolar And Bipolar Electrosurgical Instruments

Electrosurgical, Cutting & Coagulation & Accessories

Integra MicroFrance

The following data is part of a premarket notification filed by Integra Microfrance with the FDA for Microfrance Monopolar And Bipolar Electrosurgical Instruments.

Pre-market Notification Details

Device IDK210942
510k NumberK210942
Device Name:MicroFrance Monopolar And Bipolar Electrosurgical Instruments
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Integra MicroFrance Le Pavillon Saint Aubin Le Monial Allier,  FR 03160
ContactMalena Zammetti
CorrespondentMalena Zammetti
Integra MicroFrance Le Pavillon Saint Aubin Le Monial Allier,  FR 03160
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-30
Decision Date2021-05-14

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