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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Metal Clip For The Gi Tract
510(k) Number K213338
Device Name CORE-CLIP
Applicant
Incore Co., Ltd.
11, Hyeoksin-daero, 78-gil, Dong-gu
Daegu,  KR 41072
Applicant Contact Jae-Hun Lee
Correspondent
KMC,Inc.
Room no. 1709, 123, Digital-ro 26-gil, Guro-gu
Seoul,  KR 08390
Correspondent Contact Seon-mi Kim
Regulation Number876.4400
Classification Product Code
PKL  
Date Received10/07/2021
Decision Date 06/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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