510(k) K982760 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET
| Applicant | Gambro Healthcare, Lakewood CO, US |
| Decision | Substantially Equivalent, Nov 4, 1998 |
| Received | Aug 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982760
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.