510(k) K974584 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS
| Applicant | Fresenius USA, Inc., Walnut Creek CA, US |
| Decision | Substantially Equivalent, May 14, 1998 |
| Received | Dec 8, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974584
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.