510(k) K103362 ยท MVA Orthosis, Cranial
AOI CRANIAL HELMET
| Applicant | Advanced Orthopro, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 18, 2011 |
| Received | Nov 17, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103362
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.