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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name snare, flexible
510(k) Number K172729
Device Name Polypectomy Snare
Applicant
Hangzhou AGS MedTech CO., Ltd
Building 6, Kangxin Road No.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 Number876.4300
Classification Product Code
FDI  
Date Received09/11/2017
Decision Date 05/21/2018
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
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