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FDA 510(k) Application Details - K171076
Device Classification Name
Ureteroscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K171076
Device Name
Ureteroscope And Accessories, Flexible/Rigid
Applicant
Zhuhai Pusen Medical Technology Co., Ltd.
5/F, Building 1, No 33, Keji San Road
High-tech Zone,Tangjiawan Town
Zhuhai 519085 CN
Other 510(k) Applications for this Company
Contact
Wang ChangShen
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FGB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/11/2017
Decision Date
05/05/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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