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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 K203013
Device Name AGNES
Agnes Medical CO., LTD
(Seohyeon-Dong, 5fCocoplaza), 20, Seohyeon-Ro 210beon-Gil,
Seongnam-Si,  KR 13591
Applicant Contact Chul Lee
KMC, Inc.
Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu
Seoul,  KR 08375
Correspondent Contact DongHa Lee
Regulation Number878.4400
Classification Product Code
Subsequent Product Code
Date Received10/01/2020
Decision Date 07/14/2022
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