510(k) K051190 ยท PAJ Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
XENFORM SOFT TISSUE REPAIR MATRIX
| Applicant | Tei Biosciences, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Jun 10, 2005 |
| Received | May 10, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051190
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.