FDA 510(k) Application Details - K961906

Device Classification Name	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile   More FDA Info for this Device
510(K) Number	K961906
Device Name	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Applicant	SPECTRUM MEDSYSTEMS CORP. 2166 MICHELSON DR. IRVINE, CA 92715-1304 US Other 510(k) Applications for this Company
Contact	THOMAS L HURSMAN Other 510(k) Applications for this Contact
Regulation Number	876.5250   More FDA Info for this Regulation Number
Classification Product Code	EYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/1996
Decision Date	11/19/1996
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