510(k) K034064 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
FRESENIUS ULTRAFLO HPX HEMODIALYZER
| Applicant | Fresenius Medical Care North America, Lexington MA, US |
| Decision | Substantially Equivalent, Jan 30, 2004 |
| Received | Dec 31, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K034064
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.