510(k) K062570 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
PATIENT CONTOURED MESH (PCM)
| Applicant | KLS-Martin L.P., Jacksonville FL, US |
| Decision | Substantially Equivalent, Oct 31, 2006 |
| Received | Aug 31, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062570
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.