510(k) K850979 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
HEMOCONCENTRATOR KIT
| Applicant | Omnis Surgical, Inc., Deerfield IL, US |
| Decision | Substantially Equivalent, Jul 29, 1985 |
| Received | Mar 8, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850979
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.