510(k) K971408 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)
| Applicant | Ikonos Corp., Portland OR, US |
| Decision | Substantially Equivalent, May 12, 1998 |
| Received | Apr 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971408
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.