510(k) K200041 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
FlexPointer 1.5 Single Use, FlexTube 3 Single Use
| Applicant | Fiagon GmbH, Hennigsdorf, DE |
| Decision | Substantially Equivalent, Mar 10, 2020 |
| Received | Jan 8, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200041
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.