510(k) K181539 ยท GXR Cover, Burr Hole
OSSDSIGN Cranioplug
| Applicant | Ossdsign AB, Uppsala, SE |
| Decision | Substantially Equivalent, Oct 12, 2018 |
| Received | Jun 11, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181539
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.