510(k) K896599

DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET -(8) by National Medical Care, Medical Products Div., Inc. — Product Code KDJ

K896599 is an FDA 510(k) premarket notification submitted by National Medical Care, Medical Products Div., Inc. for the device "DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET -(8)". The FDA issued a decision of Substantially Equivalent on March 22, 1990. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. National Medical Care, Medical Products Div., Inc. has at least 10 other 510(k) clearances on record.