510(k) K160479 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
PointerShell Universal, PointerShell LS
| Applicant | Fiagon GmbH, Hennigsdorf, DE |
| Decision | Substantially Equivalent, Mar 23, 2016 |
| Received | Feb 22, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160479
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.