510(k) K083778 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210
| Applicant | Baxter Healthcare Corporation, Mcgaw Park IL, US |
| Decision | Substantially Equivalent, Feb 20, 2009 |
| Received | Dec 19, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083778
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.