510(k) K123835 ยท FKT System, Dialysate Delivery, Sorbent Regenerated
2008 HEMODIALYSIS SORBENT SYSTEM
| Applicant | Renal Solutions, Inc., Warrendale PA, US |
| Decision | Substantially Equivalent, Feb 15, 2013 |
| Received | Dec 13, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123835
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.