510(k) K170368 ยท GWO Plate, Cranioplasty, Preformed, Alterable
Sterile NS System
| Applicant | Jeil Medical Corporation, Seoul, KR |
| Decision | Substantially Equivalent, Sep 11, 2017 |
| Received | Feb 6, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170368
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.