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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 K200217
Device Name ClearEndoclip
Applicant
Finemedix Co., Ltd.
60, Maeyeo-Ro, Dong-Gu
Daegu,  KR 41065
Applicant Contact H. S. Lee
Correspondent
K-Bio Solutions
589 Oakwood Dr.
Santa Clara,  CA  95054
Correspondent Contact Kyungyoon Kang
Regulation Number876.4400
Classification Product Code
PKL  
Subsequent Product Codes
FHN   MND  
Date Received01/28/2020
Decision Date 10/05/2020
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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