510(k) K013458 ยท MVA Orthosis, Cranial
CRANIAL HELMET
| Applicant | Children'S Hospital, Minneapolis MN, US |
| Decision | Substantially Equivalent, Oct 29, 2001 |
| Received | Oct 18, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013458
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.