FDA 510(k) Application Details - K200134

Device Classification Name	Catheter, Urethral   More FDA Info for this Device
510(K) Number	K200134
Device Name	Catheter, Urethral
Applicant	Hangzhou Jimushi Meditech Co., Ltd. 5F, Building 2, No. 12 Longtan Road, Cangqian Street, Yuhang District Hangzhou CN Other 510(k) Applications for this Company
Contact	Fenlong Wu Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	GBM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/2020
Decision Date	06/01/2020
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