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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 K234140
Device Name VIVA combo RF System (VIVA combo RF System)
Applicant
Starmed Co., Ltd.
B-Dong, 4f&12f, 158, Haneulmaeul-Ro,
Ilsandong-Gu
Goyang-Si,  KR 10355
Applicant Contact Honggeun Lee
Correspondent
JNM Korea
#207,#206 Bldg., Gunpo It Valley
17, Gosan-Ro 148beon-Gil
Gunpo-Si,  KR 15850
Correspondent Contact Bobae Jung
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/29/2023
Decision Date 01/30/2024
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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