510(k) K132061 ยท OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
RESTORELLE M, RESTORELLE XL
| Applicant | Coloplast Corp., Minneapolis MN, US |
| Decision | Substantially Equivalent, Aug 2, 2013 |
| Received | Jul 3, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132061
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.