510(k) K181382 ยท GXR Cover, Burr Hole
GuardianTM Burr Hole Cover System
| Applicant | St Jude Medical, Plano TX, US |
| Decision | Substantially Equivalent, Jul 20, 2018 |
| Received | May 25, 2018 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K181382
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.