510(k) K053539 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
| Applicant | Baxter Healthcare Corporation, Mcgaw Park IL, US |
| Decision | Substantially Equivalent, May 24, 2006 |
| Received | Dec 20, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053539
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.