FDA 510(k) Application Details - K970799

Device Classification Name	Dialyzer Reprocessing System   More FDA Info for this Device
510(K) Number	K970799
Device Name	Dialyzer Reprocessing System
Applicant	ALEXANDER MFG. CO. 1511 S GARFIELD PL MASON CITY, IA 50401 US Other 510(k) Applications for this Company
Contact	STACEY HIPPEN Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/1997
Decision Date	05/14/1997
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