510(k) K171271 ยท OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Polyform Synthetic Mesh
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Dec 15, 2017 |
| Received | May 1, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K171271
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.