510(k) K100205 ยท GWO Plate, Cranioplasty, Preformed, Alterable
FRONTIER DEVICES NEURO SYSTEM
| Applicant | Folsom Metal Products, Inc., Pelham AL, US |
| Decision | Substantially Equivalent, Dec 13, 2010 |
| Received | Jan 25, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100205
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.