510(k) K151147 ยท OAN Orthosis, Cranial, Laser Scan
STARband, STARlight
| Applicant | Orthomerica Products, Inc., Orlando FL, US |
| Decision | Substantially Equivalent, Jul 1, 2015 |
| Received | Apr 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151147
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.