510(k) K990643 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015
| Applicant | Althin Medical AB an Affiliate of Baxter Intl, Miami Lakes FL, US |
| Decision | Substantially Equivalent, Dec 7, 1999 |
| Received | Feb 26, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990643
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.