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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K213578
Device Name Balloon Dilatation Catheter
Applicant
Hangzhou Ags Medtech Co., Ltd.
Bldg. 5,Bldg. 6, #597 Kangxin Rd. Yuhang District
Hangzhou,  CN 311106
Applicant Contact Jiayuan Zhang
Correspondent
Hangzhou Ags Medtech Co., Ltd.
Bldg. 5,Bldg. 6, #597 Kangxin Rd. Yuhang District
Hangzhou,  CN 311106
Correspondent Contact Jiayuan Zhang
Regulation Number876.1500
Classification Product Code
FDF  
Subsequent Product Codes
FDS   KNQ  
Date Received11/10/2021
Decision Date 04/06/2022
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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