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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 K193355
Device Name Electrodes Handpieces for Mygen V-1000 RF System
Applicant
RF Medical Co., Ltd.
#502, 503, 506, 511, 254, Beotkkot-Ro, Geumcheon-Gu
Seoul,  KR
Applicant Contact Kwang S Choi
Correspondent
Mtechgroup
7707 Fannin St. Suite 200 V111
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/04/2019
Decision Date 08/03/2020
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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