510(k) K083499 ยท OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
| Applicant | Coloplast A/S, Minneapolis MN, US |
| Decision | Substantially Equivalent, May 8, 2009 |
| Received | Nov 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083499
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.