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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 K232450
Device Name Disposable Hemostatic Clips
Applicant
Zhejiang Soudon Medical Technology Co., Ltd.
Rm. 302-1, Floor 3, Bldg. 4, #1 Nangonghe Rd.,
Donghu St., Linping District
Hangzhou,  CN 311100
Applicant Contact Junshi Wang
Correspondent
Shanghai Vanhe Consulting Co., Ltd.
2f, Bldg. #1, 3938 Huqingping Rd., Qingpu District
Shanghai,  CN 201703
Correspondent Contact Nick Wang
Regulation Number876.4400
Classification Product Code
PKL  
Date Received08/14/2023
Decision Date 01/26/2024
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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