FDA 510(k) Application Details - K971271

Device Classification Name	Collector, Urine, (And Accessories) For Indwelling Catheter   More FDA Info for this Device
510(K) Number	K971271
Device Name	Collector, Urine, (And Accessories) For Indwelling Catheter
Applicant	UROLOGY RESEARCH INTL., INC. P.O. BOX 02544 CLEVELAND, OH 44102 US Other 510(k) Applications for this Company
Contact	FRANK A MANFREDI 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	04/04/1997
Decision Date	08/18/1997
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