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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 K234124
Device Name Single Use Hemoclips
Applicant
Promisemed Hangzhou Meditech Co., Ltd.
# 1388 Cangxing St.
Cangqian Community, Yuhang District
Hangzhou City,  CN 311121
Applicant Contact Zearou Yang
Correspondent
Promisemed Hangzhou Meditech Co., Ltd.
# 1388 Cangxing St.
Cangqian Community, Yuhang District
Hangzhou City,  CN 311121
Correspondent Contact Zearou Yang
Regulation Number876.4400
Classification Product Code
PKL  
Date Received12/28/2023
Decision Date 07/12/2024
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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