FDA 510(k) Application Details - K962604

Device Classification Name	Bag, Urine Collection, Leg, For External Use, Sterile   More FDA Info for this Device
510(K) Number	K962604
Device Name	Bag, Urine Collection, Leg, For External Use, Sterile
Applicant	CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 100 HEADQUARTERS PARK DR. SKILLMAN, NJ 08558 US Other 510(k) Applications for this Company
Contact	GEORGE J PRENDERGAST Other 510(k) Applications for this Contact
Regulation Number	876.5250   More FDA Info for this Regulation Number
Classification Product Code	FAQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/1996
Decision Date	07/18/1996
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