510(k) K060989 ยท FTM Mesh, Surgical
TISSUEMEND SOFT TISSUE REPAIR MATRIX
| Applicant | Tei Biosciences, Inc., Boston MA, US |
| Decision | Substantially Equivalent, May 15, 2006 |
| Received | Apr 10, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060989
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2024 | TEI Biosciences, Inc. TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm. Open, Classified |
FTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.