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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 K211787
Device Name Hemoclip
Applicant
Hangzhou AGS MedTech Co., Ltd.
Bldg. 5,Bldg. 6, #597 Kangxin Rd. Yuhang District
Hangzhou,  CN 311106
Applicant Contact Yanping Fu
Correspondent
Hangzhou AGS MedTech Co., Ltd.
Bldg. 5,Bldg. 6, #597 Kangxin Rd. Yuhang District
Hangzhou,  CN 311106
Correspondent Contact Yanping Fu
Regulation Number876.4400
Classification Product Code
PKL  
Date Received06/09/2021
Decision Date 03/03/2022
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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