ClearanceBrief
510(k) K980658 ยท FJI Dialyzer, Capillary, Hollow Fiber

PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234

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

Recalls that name K980658

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.