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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
510(k) Number K200173
Device Name Stone Retrieval Balloon
Applicant
Hangzhou AGS MedTech Co., Ltd.
Bldg. 5,Bldg. 6, #597 Kangxin Rd. Yuhang District
Hangzhou,  CN 311106
Applicant Contact Chunqi Han
Correspondent
Hangzhou AGS MedTech Co., Ltd.
Bldg. 5,Bldg. 6, #597 Kangxin Rd. Yuhang District
Hangzhou,  CN 311106
Correspondent Contact Chunqi Han
Regulation Number876.5010
Classification Product Code
GCA  
Date Received01/23/2020
Decision Date 05/01/2020
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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