FDA 510(k) Application Details - K213015

Device Classification Name	Needle, Fistula   More FDA Info for this Device
510(K) Number	K213015
Device Name	Needle, Fistula
Applicant	Bain Medical Equipment (Guangzhou)Co., Ltd. No.10, Juncheng Road, Eastern Area, Economic and Technological Development Guangzhou 510760 CN Other 510(k) Applications for this Company
Contact	Zoe Zeng 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	09/20/2021
Decision Date	04/08/2022
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