510(k) K041215 ยท MVA Orthosis, Cranial
CRANIAL HELMET
| Applicant | Otto Bock Healthcare LP, Minneapolis MN, US |
| Decision | Substantially Equivalent, Sep 9, 2004 |
| Received | May 10, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041215
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.