510(k) K963668

MEDISYSTEMS PERITONEAL DIALYSIS SETS by Medisystems Corp. — Product Code KDJ

K963668 is an FDA 510(k) premarket notification submitted by Medisystems Corp. for the device "MEDISYSTEMS PERITONEAL DIALYSIS SETS". The FDA issued a decision of Substantially Equivalent on August 15, 1997. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Medisystems Corp. has at least 10 other 510(k) clearances on record.