510(k) K183374 ยท IYE Accelerator, Linear, Medical
GrayDuck Stent
| Applicant | Poll Medical, LLC, Beaverton OR, US |
| Decision | Substantially Equivalent, Feb 26, 2019 |
| Received | Dec 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183374
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.