510(k) K031099 ยท FKT System, Dialysate Delivery, Sorbent Regenerated
SORB+HISORB+CARTRIDGE
| Applicant | Renal Solutions, Inc., Apollo PA, US |
| Decision | Substantially Equivalent, Sep 17, 2003 |
| Received | Apr 7, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031099
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.