510(k) K011350 ยท OAN Orthosis, Cranial, Laser Scan
STARBAND CRANIAL ORTHOSIS
| Applicant | Orthomerica Products, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Jul 3, 2001 |
| Received | May 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011350
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.