510(k) K801440

SORB 10 DIALYSATE INFUSATE C1 INFUSATE by Organon Teknika Corp. — Product Code FKT

K801440 is an FDA 510(k) premarket notification submitted by Organon Teknika Corp. for the device "SORB 10 DIALYSATE INFUSATE C1 INFUSATE". The FDA issued a decision of Substantially Equivalent on July 21, 1980. 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 at least 10 other 510(k) clearances on record.