510(k) K040255 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE
| Applicant | Gambro Renal Products, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, May 24, 2004 |
| Received | Feb 4, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040255
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.