510(k) K994390 ยท MSF Hemodialyzer, Re-Use, High Flux
GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER
| Applicant | Gambro Healthcare, Lakewood CO, US |
| Decision | Substantially Equivalent, Oct 26, 2000 |
| Received | Dec 28, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994390
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.