510(k) K112386 ยท OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
| Applicant | Coloplast Corp., Minneapolis MN, US |
| Decision | Substantially Equivalent, Sep 8, 2011 |
| Received | Aug 18, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112386
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.