510(k) K223238 ยท MVA Orthosis, Cranial
STARband 3D
| Applicant | Orthomerica Products, Inc., Orlando FL, US |
| Decision | Substantially Equivalent, Apr 20, 2023 |
| Received | Oct 20, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223238
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.