510(k) K113822 ยท HCG Device, Neurovascular Embolization
QUADRASPHERE 30 TO 60
| Applicant | Biosphere Medical, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Mar 8, 2012 |
| Received | Dec 27, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113822
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.