510(k) K974090 ยท MSE Hemodialyzer, Re-Use, Low Flux
95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
| Applicant | Fresenius Medical Care North America, Walnut Creek CA, US |
| Decision | Substantially Equivalent, Aug 27, 1998 |
| Received | Oct 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974090
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.