510(k) K010805 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRISMA SYSTEM
| Applicant | Gambro Renal Products, Lakewood CO, US |
| Decision | Substantially Equivalent, Aug 6, 2002 |
| Received | Mar 16, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K010805
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2005 | Gambro Renal Products Prisma continuous renal replacement system. Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.