510(k) K872767

FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER by Hospal Medical Corp. — Product Code KDI

K872767 is an FDA 510(k) premarket notification submitted by Hospal Medical Corp. for the device "FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER". The FDA issued a decision of Substantially Equivalent on December 29, 1987. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. Hospal Medical Corp. has at least 10 other 510(k) clearances on record.