FDA 510(k) Application Details - K180801

Device Classification Name	Catheter, Urethral   More FDA Info for this Device
510(K) Number	K180801
Device Name	Catheter, Urethral
Applicant	B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109 US Other 510(k) Applications for this Company
Contact	Anita J. Nemeth 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	03/28/2018
Decision Date	11/05/2018
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