510(k) K915628

DEXTROLYTE II PERITONEAL DIALYSIS PUMP by National Medical Care, Medical Products Div., Inc. — Product Code KDJ

K915628 is an FDA 510(k) premarket notification submitted by National Medical Care, Medical Products Div., Inc. for the device "DEXTROLYTE II PERITONEAL DIALYSIS PUMP". The FDA issued a decision of Substantially Equivalent on March 16, 1992. 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.