510(k) K133299 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY
| Applicant | Fresenius Medical Care, North America - Renal Ther, Waltham MA, US |
| Decision | Substantially Equivalent, Jul 7, 2014 |
| Received | Oct 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133299
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.