FDA 510(k) Application Details - K011741

Device Classification Name	System, Dialysate Delivery, Single Pass   More FDA Info for this Device
510(K) Number	K011741
Device Name	System, Dialysate Delivery, Single Pass
Applicant	HEMAMETRICS 695 NORTH, 900 WEST KAYSVILLE, UT 84037 US Other 510(k) Applications for this Company
Contact	MATTHEW L HAYNIE Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FIL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/05/2001
Decision Date	07/23/2002
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