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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 K241005
Device Name Haemostasis Clips
Applicant
Jiangxi Zhuoruihua Medical Instrument Co., Ltd.
14th Industrial Bldg., Xiajiang Industrial Zone
Xiajiang
Ji'An,  CN 343000
Applicant Contact Qin Xu
Correspondent
Sinow Medical AS
Høyteknologisenteret, Thormøhlens Gate 55
Bergen,  NO 5008
Correspondent Contact Xiaoqing Xue
Regulation Number876.4400
Classification Product Code
PKL  
Date Received04/12/2024
Decision Date 01/02/2025
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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