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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 K240311
Device Name JETT Medical II
Applicant
Compex, Spol, S.R.O.
Palackeho Trida 924/105
Brno,  CZ 61200
Applicant Contact Radek Nespor
Correspondent
Compex, Spol, S.R.O.
Palackeho Trida 924/105
Brno,  CZ 61200
Correspondent Contact Rob Packard
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/02/2024
Decision Date 01/22/2025
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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