510(k) K070512 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
MODIFICATION TO AQUADEX FLEXFLOW SYSTEM
| Applicant | Chf Solutions, Inc., Brooklyn Park Mn MN, US |
| Decision | Substantially Equivalent, Apr 27, 2007 |
| Received | Feb 22, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070512
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.