510(k) K801385 ยท FKT System, Dialysate Delivery, Sorbent Regenerated
K1 POTASSIUM ACETATE ADDITIVE
| Applicant | Organon Teknika Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 21, 1980 |
| Received | Jun 13, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801385
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.