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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 K222709
Device Name Retraction, CWM-910T, APOLEX Tite
Applicant
Chungwoo Co., Ltd.
(Gasan-Dong, Woolim Lionsvally-2), 614, 2,
Gasandigital 1-Ro, Geumcheon-Gu
Seoul,  KR 08591
Applicant Contact Il Kwon Lee
Correspondent
KMC, Inc.
(G-Plus Tower, #1709) 123, Digital-Ro 26-Gil, Guro-Gu
Seoul,  KR 08390
Correspondent Contact Milly ,
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/08/2022
Decision Date 03/21/2023
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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