510(k) K882428 ยท FKT System, Dialysate Delivery, Sorbent Regenerated
REDY 2000
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Oct 25, 1988 |
| Received | Jun 13, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882428
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.