510(k) K871108 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER
| Applicant | Gambro, Inc., Lincolnshire IL, US |
| Decision | Substantially Equivalent, May 15, 1987 |
| Received | Mar 19, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871108
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.