510(k) K842513

HEMOPERFUSION PROCEDURE W/REDY 2000 by Organon Teknika Corp. — Product Code FKT

K842513 is an FDA 510(k) premarket notification submitted by Organon Teknika Corp. for the device "HEMOPERFUSION PROCEDURE W/REDY 2000". The FDA issued a decision of Substantially Equivalent on Sep 12, 1984. The device falls under product code FKT (System, Dialysate Delivery, Sorbent Regenerated), a Class II device regulated under 21 CFR 876.5600. Organon Teknika Corp. has 129 other 510(k) clearances on record.