510(k) K083158 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
EXALIS, SOFTWARE VERSION 1.15
| Applicant | Gambro, Inc., Denver CO, US |
| Decision | Substantially Equivalent, Jun 5, 2009 |
| Received | Oct 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083158
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.