510(k) K081787 ยท OAN Orthosis, Cranial, Laser Scan
CAMLAB CRANIAL ORTHOSIS HELMET
| Applicant | Biosculptor Corporation, Hialeah FL, US |
| Decision | Substantially Equivalent, Jan 27, 2009 |
| Received | Jun 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081787
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.