510(k) K921134

FRESENIUS POLYSULFONE DIALYZERS by Fresenius USA, Inc. — Product Code KDI

K921134 is an FDA 510(k) premarket notification submitted by Fresenius USA, Inc. for the device "FRESENIUS POLYSULFONE DIALYZERS". The FDA issued a decision of Substantially Equivalent on December 2, 1993. 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. Fresenius USA, Inc. has at least 10 other 510(k) clearances on record.