510(k) K030592 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
GAMBRO POLYFLUX, MODEL 140H, 170H, 210H
| Applicant | Gambro Renal Care Products, Lakewood CO, US |
| Decision | Substantially Equivalent, May 23, 2003 |
| Received | Feb 25, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030592
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.