510(k) K970253 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET
| Applicant | Gambro Healthcare, Lakewood CO, US |
| Decision | Substantially Equivalent, Sep 26, 1997 |
| Received | Jan 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970253
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.