510(k) K063098 ยท OAN Orthosis, Cranial, Laser Scan
STATIC CRANIOPLASTY ORTHOSIS
| Applicant | Boston Brace Intl., Inc., Avon MA, US |
| Decision | Substantially Equivalent, Apr 11, 2007 |
| Received | Oct 10, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063098
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.