510(k) K904967 ยท FKP System, Dialysate Delivery, Single Patient
HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL
| Applicant | Gambro-Hosp-Cobe, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Jan 28, 1991 |
| Received | Nov 5, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904967
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.