510(k) K211376 ยท OAN Orthosis, Cranial, Laser Scan
STARband
| Applicant | Orthomerica Products, Inc., Orlando FL, US |
| Decision | Substantially Equivalent, Aug 17, 2021 |
| Received | May 4, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211376
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.