510(k) K951311 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
GAMBRO HC 14R HEMOCONCENTRATOR
| Applicant | Cobe Renal Care, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Jan 11, 1996 |
| Received | Mar 22, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951311
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.