510(k) K854309 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
GAMBRO BLOOD CONCENTRATOR SETS 16,60,200
| Applicant | Gambro, Inc., Lincolnshire IL, US |
| Decision | Substantially Equivalent, Dec 13, 1985 |
| Received | Oct 25, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854309
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.