FDA 510(k) Application Details - K123835

Device Classification Name	System, Dialysate Delivery, Sorbent Regenerated   More FDA Info for this Device
510(K) Number	K123835
Device Name	System, Dialysate Delivery, Sorbent Regenerated
Applicant	RENAL SOLUTIONS, INC. 770 COMMONWEALTH DR. WARRENDALE, PA 15086 US Other 510(k) Applications for this Company
Contact	DAVID VANELLA Other 510(k) Applications for this Contact
Regulation Number	876.5600   More FDA Info for this Regulation Number
Classification Product Code	FKT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2012
Decision Date	02/15/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review