FDA 510(k) Application Details - K960217

Device Classification Name	Bag, Urine Collection, Leg, For External Use, Sterile   More FDA Info for this Device
510(K) Number	K960217
Device Name	Bag, Urine Collection, Leg, For External Use, Sterile
Applicant	CUSTOM PACK RELIABILITY 4207 VINELAND ROAD, M-1 ORLANDO, FL 32811 US Other 510(k) Applications for this Company
Contact	RICHARD L ELLWOOD 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	01/16/1996
Decision Date	03/28/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review