510(k) K860938 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS
| Applicant | Gambro, Inc., Lincolnshire IL, US |
| Decision | Substantially Equivalent, Apr 7, 1986 |
| Received | Mar 12, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860938
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.