510(k) K063183 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRISMA M10 PRE SET
| Applicant | Gambro Renal Products, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Feb 15, 2007 |
| Received | Oct 19, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063183
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.