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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 K232763
Device Name Electrode Handpieces (VCT, RFTV, BMDT series)
Applicant
RF Medical Co., Ltd.
#502, 503, 505, 506, 507, 511, 254, Beotkkot-Ro
Geumcheon-Gu
Seoul,  KR 08513
Applicant Contact Kwang S Choi
Correspondent
Mtech Group, LLC
7505 Fannin St. Suite 610
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
JOS  
Date Received09/08/2023
Decision Date 10/04/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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