510(k) K972731

NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET by Klein-Baker Medical, Inc. — Product Code KDJ

K972731 is an FDA 510(k) premarket notification submitted by Klein-Baker Medical, Inc. for the device "NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on September 29, 1997. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Klein-Baker Medical, Inc. has at least 4 other 510(k) clearances on record.