FDA 510(k) Application Details - K151772

Device Classification Name	Catheter, Urethral   More FDA Info for this Device
510(K) Number	K151772
Device Name	Catheter, Urethral
Applicant	B. BRAUN MEDICAL INC. 901 MARCON BLVD. ALLENTOWN, PA 18109 US Other 510(k) Applications for this Company
Contact	SIERRA M. MERTZ 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	06/30/2015
Decision Date	02/09/2016
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