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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K210942
Device Name MicroFrance Monopolar and Bipolar Electrosurgical Instruments
Applicant
Integra Microfrance
Le Pavillon
Saint Aubin Le Monial Allier,  FR 03160
Applicant Contact Malena Zammetti
Correspondent
Integra Microfrance
Le Pavillon
Saint Aubin Le Monial Allier,  FR 03160
Correspondent Contact Malena Zammetti
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/30/2021
Decision Date 05/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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