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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K172098
Device Name Medical Video Endoscope System
Applicant
Zhuhai Pusen Medical Technology Co., Ltd.
5/F, Building 1, No 33, Keji San Road
High-tech Zone,Tangjiawan Town
Zhuhai,  CN 519085
Applicant Contact WANG CHANGSHEN
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number876.1500
Classification Product Code
FGB  
Date Received07/11/2017
Decision Date 08/31/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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