510(k) K130447 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
SPEEDY FLAP SYSTEM
| Applicant | Jeil Medical Corporation, Seoul, KR |
| Decision | Substantially Equivalent, Dec 22, 2014 |
| Received | Feb 21, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130447
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.