FDA 510(k) Application Details - K973364

Device Classification Name	Collector, Urine, (And Accessories) For Indwelling Catheter   More FDA Info for this Device
510(K) Number	K973364
Device Name	Collector, Urine, (And Accessories) For Indwelling Catheter
Applicant	MAERSK MEDICAL A/S HARLEV MARK 2 HARLEV 4652 DK Other 510(k) Applications for this Company
Contact	JOERGEN M NIELSEN Other 510(k) Applications for this Contact
Regulation Number	876.5250   More FDA Info for this Regulation Number
Classification Product Code	KNX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/1997
Decision Date	03/17/1998
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