510(k) K080442 ยท FTL Mesh, Surgical, Polymeric
SERISCAFFOLD SURGICAL MESH
| Applicant | Serica Technologies, Inc., Medford MA, US |
| Decision | Substantially Equivalent, Nov 13, 2008 |
| Received | Feb 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080442
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2013 | Allergen Medical SeriScaffold Surgical Scaffold
Product Number: SCF10X25AGEN.
Surgical mesh for use in open or laparoscopic procedures. Terminated |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.