510(k) K171548 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter
| Applicant | Wilson-Cook Medical, Inc., Winston-Salem NC, US |
| Decision | Substantially Equivalent, Oct 13, 2017 |
| Received | May 26, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171548
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.