FDA 510(k) Application Details - K062061

Device Classification Name	Collector, Urine, Powered, Non Indwelling Catheter   More FDA Info for this Device
510(K) Number	K062061
Device Name	Collector, Urine, Powered, Non Indwelling Catheter
Applicant	PREFERRED MEDICAL DEVICES, INC. 8 GRAY LODGE ROAD KITTERY, ME 03904 US Other 510(k) Applications for this Company
Contact	PENELOPE GRECO Other 510(k) Applications for this Contact
Regulation Number	876.5250   More FDA Info for this Regulation Number
Classification Product Code	NZU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/20/2006
Decision Date	10/05/2006
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