510(k) K970700 ยท MSE Hemodialyzer, Re-Use, Low Flux
FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
| Applicant | Fresenius USA, Inc., Walnut Creek CA, US |
| Decision | Substantially Equivalent, Sep 15, 1998 |
| Received | Feb 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970700
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.