510(k) K240466 ยท OAN Orthosis, Cranial, Laser Scan
STARband 3D
| Applicant | Orthomerica Products, Inc., Orlando FL, US |
| Decision | Substantially Equivalent, Mar 15, 2024 |
| Received | Feb 16, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K240466
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.