510(k) K991520 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION
| Applicant | Fresenius Medical Care North America, Lexington MA, US |
| Decision | Substantially Equivalent, Jul 30, 1999 |
| Received | May 3, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991520
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.