FDA 510(k) Application Details - K941757

Device Classification Name	Dialyzer Reprocessing System   More FDA Info for this Device
510(K) Number	K941757
Device Name	Dialyzer Reprocessing System
Applicant	NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. RESERVOIR PLACE 1601 TRAPELO ROAD WALTHAM, MA 02154 US Other 510(k) Applications for this Company
Contact	PAUL GENOA 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	04/08/1994
Decision Date	01/22/1996
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