ClearanceBrief
510(k) K090002 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A

ApplicantBaxter Healthcare Corp, Mcgaw Park IL, US
DecisionSubstantially Equivalent, Aug 7, 2009
ReceivedJan 2, 2009
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K090002

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.