510(k) K090682 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00
| Applicant | Edwards Lifesciences Services GmbH, Welwyn Garden City, GB |
| Decision | Substantially Equivalent, Nov 19, 2009 |
| Received | Mar 16, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090682
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.