510(k) K021918 ยท OAN Orthosis, Cranial, Laser Scan
CLARREN HELMET (ORTHOMERICA)
| Applicant | Orthomerica Products, Inc., Orlando FL, US |
| Decision | Substantially Equivalent, Jul 25, 2002 |
| Received | Jun 11, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021918
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.