510(k) K122968 ยท OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
| Applicant | Coloplast Corp., Minneapolis MN, US |
| Decision | Substantially Equivalent, Dec 18, 2012 |
| Received | Sep 25, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122968
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.