510(k) K070643 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35
| Applicant | Gambro, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Nov 2, 2007 |
| Received | Mar 8, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070643
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.