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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name low power electrosurgical devices for skin lesion destruction
510(k) Number K213247
Device Name JETT PLASMA Medical II
Applicant
Compex, Spol. s.r.o
Palackeho Trida 924/105
Brno,  CZ 61200
Applicant Contact Eva Hamplova
Correspondent
Medical Device Academy Inc.
345 Lincoln Hill Road
Shrewsbury,  VT  05738
Correspondent Contact Robert V Packard
Regulation Number878.4400
Classification Product Code
QVJ  
Date Received09/30/2021
Decision Date 03/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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