510(k) K050603

OLPUR DIALYZER, MODEL HD 190 by Nephros, Inc. — Product Code KDI

K050603 is an FDA 510(k) premarket notification submitted by Nephros, Inc. for the device "OLPUR DIALYZER, MODEL HD 190". The FDA issued a decision of Substantially Equivalent on June 9, 2005. 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. Nephros, Inc. has at least 8 other 510(k) clearances on record.