FDA 510(k) Application Details - K233094

Device Classification Name	Catheter, Urological (Antimicrobial) And Accessories   More FDA Info for this Device
510(K) Number	K233094
Device Name	Catheter, Urological (Antimicrobial) And Accessories
Applicant	Well Lead Medical (Hainan) Co., Ltd. No. 39, Mei'an 3rd Street, Mei'an Ecological Science Park Haikou 571157 CN Other 510(k) Applications for this Company
Contact	Jenny Zhu Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	MJC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2023
Decision Date	06/06/2024
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