510(k) K823115

NATURALYTE BICARBONATE DIALYSATE 4400 by Erika, Inc. — Product Code KRO

K823115 is an FDA 510(k) premarket notification submitted by Erika, Inc. for the device "NATURALYTE BICARBONATE DIALYSATE 4400". The FDA issued a decision of Substantially Equivalent on December 3, 1982. The device falls under product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3510. Erika, Inc. has at least 10 other 510(k) clearances on record.