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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 K212669
Device Name Single Use Hemoclip
Applicant
Zhejiang Chuangxiang Medical Technology Co., LTD.
301B, No.22, XinYan Road, Yuhang District
Hangzhou,  CN 311100
Applicant Contact Lucius Long
Correspondent
Zhejiang Chuangxiang Medical Technology Co., LTD.
Room 101,201,301,401,501, Building 50,
No.650 Hongfeng Road Donghu Street, Yuhang District
Hangzhou,  CN 311100
Correspondent Contact Lucius Long
Regulation Number876.4400
Classification Product Code
PKL  
Date Received08/23/2021
Decision Date 05/27/2022
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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