510(k) K991549 ยท HCG Device, Neurovascular Embolization
EMBOSPHERE MICROSPHERES
| Applicant | Biosphere Medical, Rockland MA, US |
| Decision | Substantially Equivalent, Apr 26, 2000 |
| Received | May 3, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991549
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.