510(k) K812772

PERITONEAL DIALYSIS CYCLER SET (8UNIT) by Dravon Medical, Inc. — Product Code KDJ

K812772 is an FDA 510(k) premarket notification submitted by Dravon Medical, Inc. for the device "PERITONEAL DIALYSIS CYCLER SET (8UNIT)". The FDA issued a decision of Substantially Equivalent on October 19, 1981. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Dravon Medical, Inc. has at least 10 other 510(k) clearances on record.