FDA 510(k) Application Details - K060734

Device Classification Name	Separator, Automated, Blood Cell And Plasma, Therapeutic   More FDA Info for this Device
510(K) Number	K060734
Device Name	Separator, Automated, Blood Cell And Plasma, Therapeutic
Applicant	FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. LEXINGTON, MA 02420 US Other 510(k) Applications for this Company
Contact	JANET C KAY Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LKN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/2006
Decision Date	09/05/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review