510(k) K895405

AMICON MINIFILTER PLUS HEMOFILTER by Amicon, Inc. — Product Code KDI

K895405 is an FDA 510(k) premarket notification submitted by Amicon, Inc. for the device "AMICON MINIFILTER PLUS HEMOFILTER". The FDA issued a decision of Substantially Equivalent on January 11, 1990. 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. Amicon, Inc. has at least 10 other 510(k) clearances on record.