ClearanceBrief
510(k) K980656 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236

ApplicantBaxter Healthcare Corp, Mcgaw Park IL, US
DecisionSubstantially Equivalent, May 19, 1998
ReceivedFeb 19, 1998
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K980656

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.