510(k) K003630 ยท MVA Orthosis, Cranial
DANMAR PRODUCTS MICHIGAN CRANIAL HELMET
| Applicant | Danmar Products, Inc., Ann Arbor MI, US |
| Decision | Substantially Equivalent, May 29, 2001 |
| Received | Nov 24, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003630
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.