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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 K202415
Device Name VirtueRF
Applicant
ShenB Co., Ltd.
Shenb Bldg. 148 Seongsui-Ro
Seoul,  KR 04796
Applicant Contact Oskar Lee
Correspondent
Hoy and Associates
3916 N. Potsdam Ave. #4676
Sioux Falls,  SD  57104
Correspondent Contact Connie Hoy
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/24/2020
Decision Date 01/22/2021
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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