510(k) K123262 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
OPTIFLUX ULTRA DIALYZER
| Applicant | Fresenius Medical Care North America, Waltham MA, US |
| Decision | Substantially Equivalent, Jan 6, 2014 |
| Received | Oct 18, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123262
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.