510(k) K082950 ยท OAN Orthosis, Cranial, Laser Scan
STARBAND
| Applicant | Orthomerica Products, Inc., Orlando FL, US |
| Decision | Substantially Equivalent, Dec 5, 2008 |
| Received | Oct 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082950
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.