510(k) K083839 ยท OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
| Applicant | C.R. Bard, Inc., Covington GA, US |
| Decision | Substantially Equivalent, Jan 15, 2009 |
| Received | Dec 23, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083839
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.