510(k) K920586

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

K920586 is an FDA 510(k) premarket notification submitted by National Medical Care, Medical Products Div., Inc. for the device "DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET". The FDA issued a decision of Substantially Equivalent on September 21, 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.