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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 K210693
Device Name PLEXR PLUS
Applicant
GMV S.r.l.
Via Roberto Parabeni 37
Rome,  IT 00173
Applicant Contact Andrea Cancelli
Correspondent
GMV S.r.l.
Via Roberto Parabeni 37
Rome,  IT 00173
Correspondent Contact Andrea Cancelli
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/08/2021
Decision Date 03/22/2022
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
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