FDA 510(k) Application Details - K182511

Device Classification Name	Catheter, Urethral   More FDA Info for this Device
510(K) Number	K182511
Device Name	Catheter, Urethral
Applicant	F&S Medical Solutions, LLC 10221 Woodridge Lane Omaha, NE 68124 US Other 510(k) Applications for this Company
Contact	Sonia M. Rocha-Sanchez 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	09/12/2018
Decision Date	03/20/2019
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