510(k) K933818 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER
| Applicant | C.G.H. Medical, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Jan 25, 1995 |
| Received | Aug 4, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K933818
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.