510(k) K952342

GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS by Cobe Renal Care, Inc. — Product Code KDI

K952342 is an FDA 510(k) premarket notification submitted by Cobe Renal Care, Inc. for the device "GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS". The FDA issued a decision of Substantially Equivalent on September 15, 1995. 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. Cobe Renal Care, Inc. has at least 10 other 510(k) clearances on record.