510(k) K063395 ยท MVA Orthosis, Cranial
O&P BIVALVE CRANIAL MOLDING HELMET
| Applicant | Orthotic & Prosthetic Lab, Inc., Webster Groves MO, US |
| Decision | Substantially Equivalent, Dec 22, 2006 |
| Received | Nov 9, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063395
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.