510(k) K955487 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS
| Applicant | Cobe Renal Care, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Apr 18, 1997 |
| Received | Dec 1, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955487
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.