FDA 510(k) Application Details - K212430

Device Classification Name	Catheter, Straight   More FDA Info for this Device
510(K) Number	K212430
Device Name	Catheter, Straight
Applicant	Bonree Medical Co., Ltd No.4 Longzhu Garden, Wanmu Industrial Estate, Nanlang Zhongshan 528451 CN Other 510(k) Applications for this Company
Contact	He Hongbo Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2021
Decision Date	04/29/2022
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