510(k) K081710 ยท OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE
| Applicant | American Medical Systems, Minnetonka MN, US |
| Decision | Substantially Equivalent, Oct 15, 2008 |
| Received | Jun 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081710
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.