510(k) K160444 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
FB-U Hemodialyzer
| Applicant | Nipro Medical Corporation, Miami FL, US |
| Decision | Substantially Equivalent, Feb 8, 2017 |
| Received | Feb 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160444
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.