510(k) K152342 ยท GXR Cover, Burr Hole
Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
| Applicant | St Jude Medical, Plano TX, US |
| Decision | Substantially Equivalent, Jun 9, 2016 |
| Received | Aug 19, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152342
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.