510(k) K880459

480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE by Cd Medical, Inc. — Product Code FKP

K880459 is an FDA 510(k) premarket notification submitted by Cd Medical, Inc. for the device "480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE". The FDA issued a decision of Substantially Equivalent on April 13, 1988. The device falls under product code FKP (System, Dialysate Delivery, Single Patient), a Class II device regulated under 21 CFR 876.5820. Cd Medical, Inc. has at least 10 other 510(k) clearances on record.