FDA 510(k) Application Details - K152268

Device Classification Name	Catheter, Urethral   More FDA Info for this Device
510(K) Number	K152268
Device Name	Catheter, Urethral
Applicant	HOLLISTER INCORPORATED 2000 HOLLISTER DR LIBERTYVILLE, IL 60048 US Other 510(k) Applications for this Company
Contact	JEANNE LEE 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	08/11/2015
Decision Date	09/09/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review