ClearanceBrief
510(k) K023985 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE

ApplicantRockwell Medical Technologies, Inc., Wixom MI, US
DecisionSubstantially Equivalent, Feb 28, 2003
ReceivedDec 2, 2002
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K023985

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.