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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 K233118
Device Name DUET-V (Model: ESK-3261DV)
Applicant
Eunsung Global Corp
120, Gieopdosi-Ro, Jijeong-Myeon, ,
Wonju-Si,  KR 26354
Applicant Contact MyeongSoo Woo
Correspondent
Kmc, Inc.
(G-Plus Tower, #1709) 123, Digital-Ro 26-Gil, Guro-Gu
Seoul,  KR 08390
Correspondent Contact Milly Milly
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/27/2023
Decision Date 01/03/2025
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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