510(k) K023615 ยท MSF Hemodialyzer, Re-Use, High Flux
GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR
| Applicant | Gambro Renal Products, Lakewood CO, US |
| Decision | Substantially Equivalent, May 6, 2003 |
| Received | Oct 28, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023615
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.