510(k) K122343 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
PUREFLUX-H HEMODIALYZER
| Applicant | Nipro Medical Corporation, Suwanee GA, US |
| Decision | Substantially Equivalent, May 7, 2013 |
| Received | Aug 3, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122343
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.