510(k) K123835

2008 HEMODIALYSIS SORBENT SYSTEM by Renal Solutions, Inc. — Product Code FKT

K123835 is an FDA 510(k) premarket notification submitted by Renal Solutions, Inc. for the device "2008 HEMODIALYSIS SORBENT SYSTEM". The FDA issued a decision of Substantially Equivalent on February 15, 2013. The device falls under product code FKT (System, Dialysate Delivery, Sorbent Regenerated), a Class II device regulated under 21 CFR 876.5600. Renal Solutions, Inc. has at least 8 other 510(k) clearances on record.