510(k) K946279 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
| Applicant | Cobe Renal Care, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Feb 10, 1997 |
| Received | Dec 27, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946279
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.