510(k) K021397 ยท NAJ Agents, Embolic, For Treatment Of Uterine Fibroids
EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION
| Applicant | Biosphere Medical, Inc., North Attleboro MA, US |
| Decision | Substantially Equivalent, Nov 22, 2002 |
| Received | May 2, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021397
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.