510(k) K140116 ยท OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
RESTORELLE Y CONTOUR MESH
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, Feb 12, 2014 |
| Received | Jan 16, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140116
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.