510(k) DEN160040 ยท NOY Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Embosphere Microspheres
| Applicant | Biosphere Medical, S.A., 383 Rue De La Belle Etoile, FR |
| Decision | Unknown, Jun 21, 2017 |
| Received | Aug 5, 2016 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN160040
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.