510(k) K970648 ยท MSF Hemodialyzer, Re-Use, High Flux
PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)
| Applicant | Renal Systems, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jan 5, 1998 |
| Received | Feb 20, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970648
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.