510(k) K133447 ยท NAJ Agents, Embolic, For Treatment Of Uterine Fibroids
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
| Applicant | Celonova Biosciences, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Feb 24, 2014 |
| Received | Nov 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133447
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.