510(k) K091989 ยท KDN System, Perfusion, Kidney
PERFADEX AND PERFADEX WITH THAM
| Applicant | Xvivo Perfusion AB, Gutengurg, SE |
| Decision | Substantially Equivalent, Oct 1, 2010 |
| Received | Jul 2, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091989
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.