510(k) K820243

CONTINUOUS BLOOD PROCESSOR CBP-6000 & by Bentley Laboratories, Inc. — Product Code KDI

K820243 is an FDA 510(k) premarket notification submitted by Bentley Laboratories, Inc. for the device "CONTINUOUS BLOOD PROCESSOR CBP-6000 &". The FDA issued a decision of Substantially Equivalent on March 25, 1982. 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. Bentley Laboratories, Inc. has at least 10 other 510(k) clearances on record.