510(k) K100076 ยท FTL Mesh, Surgical, Polymeric
ATRIUM C-QUR OVT MESH
| Applicant | Atrium Medical Corp., Hudson NH, US |
| Decision | Substantially Equivalent, Jan 26, 2010 |
| Received | Jan 12, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100076
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2013 | Atrium Medical Corporation C-QUR TacShield Mesh (All sizes and shapes).
Intended for use in soft tissue deficiencies. Terminated |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.