510(k) K080650 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
OMNI-DL SYSTEM
| Applicant | Transvivo, Inc., Richmond CA, US |
| Decision | Substantially Equivalent, Nov 26, 2008 |
| Received | Mar 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080650
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.