510(k) K111247 ยท MVA Orthosis, Cranial
CRANIAL REMOLDING ORTHOSIS
| Applicant | Orthotic Care Services, Llp, St.Paul MN, US |
| Decision | Substantially Equivalent, Aug 15, 2011 |
| Received | May 3, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111247
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.