FDA 510(k) Application Details - K971929

Device Classification Name	Collector, Urine, (And Accessories) For Indwelling Catheter   More FDA Info for this Device
510(K) Number	K971929
Device Name	Collector, Urine, (And Accessories) For Indwelling Catheter
Applicant	AMSINO INTL., INC. 833 TOWNE CENTER DR. POMONA, CA 91767 US Other 510(k) Applications for this Company
Contact	RICHARD Y LI 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	05/27/1997
Decision Date	08/06/1997
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