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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 K242907
Device Name DELPHI System
Applicant
Cns Medical Co., Ltd.
94-40, Yongjeonggyeongje-Ro, 1-Gil, Gunnae-Myeon
Pocheon-Si,  KR 11154
Applicant Contact Lee Jin Wook
Correspondent
Kmc
#1709, G-Plus Tower, 123, Digital-Ro 26-Gil, Guro-Gu
Seoul,  KR 08390
Correspondent Contact Kim Jiwon
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/24/2024
Decision Date 06/06/2025
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 Yes
Predetermined Change
Control Plan Authorized		 No
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