ClearanceBrief
510(k) K011537 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS

ApplicantDynamic Technology Corp., Hsinchu, TW
DecisionSubstantially Equivalent, Jan 7, 2002
ReceivedMay 18, 2001
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K011537

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.