510(k) K813336

LAZARUS-NELSON PERITONEAL LAVAGE TRAY by American Pharmaseal Div. Ahsc — Product Code FKO

K813336 is an FDA 510(k) premarket notification submitted by American Pharmaseal Div. Ahsc for the device "LAZARUS-NELSON PERITONEAL LAVAGE TRAY". The FDA issued a decision of Substantially Equivalent on December 18, 1981. The device falls under product code FKO (Catheter, Peritoneal Dialysis, Single Use), a Class II device regulated under 21 CFR 876.5630. American Pharmaseal Div. Ahsc has at least 10 other 510(k) clearances on record.