510(k) K003035 ยท MVA Orthosis, Cranial
CLARREN HELMET
| Applicant | Children'S Hospital & Medical Center, Washington DC, US |
| Decision | Substantially Equivalent, Jun 6, 2001 |
| Received | Sep 28, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003035
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.