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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 K230968
Device Name VYBE RF Electrosurgical System
Applicant
ShenB Co., Ltd.
Shenb Bldg. 148 Seongsui-Ro
Seoul,  KR 04796
Applicant Contact Sunny Kang
Correspondent
Hoy and Associates
1830 Bonnie Way
Sacramento,  CA  95825
Correspondent Contact Connie Hoy
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/05/2023
Decision Date 07/06/2023
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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