510(k) K992275

FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS by Fresenius USA, Inc. — Product Code KDI

K992275 is an FDA 510(k) premarket notification submitted by Fresenius USA, Inc. for the device "FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS". The FDA issued a decision of Substantially Equivalent on August 4, 1999. 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.