FDA 510(k) Application Details - K043126

Device Classification Name	Dialyzer Reprocessing System   More FDA Info for this Device
510(K) Number	K043126
Device Name	Dialyzer Reprocessing System
Applicant	ALCAVIS INTERNATIONAL, INC. 8-8 METROPOLITAN CT. GAITHERSBURG, MD 20878 US Other 510(k) Applications for this Company
Contact	GARY J MISHKIN 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	11/12/2004
Decision Date	02/03/2005
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