FDA 510(k) Application Details - K163025

Device Classification Name	Needle, Fistula   More FDA Info for this Device
510(K) Number	K163025
Device Name	Needle, Fistula
Applicant	Bain Medical Equipment (Guangzhou) Co., Ltd. No.10 Juncheng Road Eastern Zone of Guangzhou E&T Development District Guangzhou 510760 CN Other 510(k) Applications for this Company
Contact	Sophia Shao Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	FIE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2016
Decision Date	07/20/2017
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	N
Expedited Review