FDA 510(k) Application Details - K172098

Device Classification Name	Ureteroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K172098
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	07/11/2017
Decision Date	08/31/2017
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