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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 K172727
Device Name Hemoclip
Applicant
Hangzhou AGS MedTech Co., Ltd.
Bldg. 6, Kangxin Rd. #597
Qianjiang Economic Development Area
Hangzhou,  CN 311106
Applicant Contact Chunqi Han
Correspondent
Shanghai Thinkwell Consulting Co., Ltd.
Xinling Rd., 211/6f
Shanghai,  CN 201100
Correspondent Contact Ethan Liu
Regulation Number876.4400
Classification Product Code
PKL  
Date Received09/11/2017
Decision Date 04/16/2018
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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