510(k) K082945 ยท OAN Orthosis, Cranial, Laser Scan
STARLIGHT
| Applicant | Orthomerica Products, Inc., Orlando FL, US |
| Decision | Substantially Equivalent, Oct 31, 2008 |
| Received | Oct 2, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082945
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.