510(k) K900018

HOLLOW FIBER DIALYZER, BIO CARE PS 130 by National Medical Care, Medical Products Div., Inc. — Product Code KDI

K900018 is an FDA 510(k) premarket notification submitted by National Medical Care, Medical Products Div., Inc. for the device "HOLLOW FIBER DIALYZER, BIO CARE PS 130". The FDA issued a decision of Substantially Equivalent on July 27, 1990. 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. National Medical Care, Medical Products Div., Inc. has at least 10 other 510(k) clearances on record.