510(k) K160369 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
GuideWire
| Applicant | Fiagon GmbH, Hennigsdorf, DE |
| Decision | Substantially Equivalent, Mar 10, 2016 |
| Received | Feb 10, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160369
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.