510(k) K141209 ยท KRD Device, Vascular, For Promoting Embolization
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES
| Applicant | Celonova Biosciences, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Aug 7, 2014 |
| Received | May 9, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141209
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.