510(k) K854367 ยท FKP System, Dialysate Delivery, Single Patient
HD-SECURA HEMADIALYSIS MACHINE
| Applicant | Organon Teknika Corp., Oklahoma City OK, US |
| Decision | Substantially Equivalent, Dec 16, 1985 |
| Received | Oct 29, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854367
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.