510(k) K982414 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS
| Applicant | Gambro Healthcare, Lakewood CO, US |
| Decision | Substantially Equivalent, Mar 26, 1999 |
| Received | Jul 13, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982414
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.