510(k) K893712

PERITONEAL DIALYSIS SYSTEM AND ACCESS. by Delmed, Inc. — Product Code KDJ

K893712 is an FDA 510(k) premarket notification submitted by Delmed, Inc. for the device "PERITONEAL DIALYSIS SYSTEM AND ACCESS.". The FDA issued a decision of Substantially Equivalent on July 24, 1989. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Delmed, Inc. has at least 10 other 510(k) clearances on record.