510(k) K050609 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
AQUADEX SYSTEM
| Applicant | Chf Solutions, Inc., Brooklyn Park Mn MN, US |
| Decision | Substantially Equivalent, Nov 9, 2005 |
| Received | Mar 10, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050609
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.