510(k) K053655 ยท FTM Mesh, Surgical
TENDON WRAP TENDON PROTECTOR
| Applicant | Integra LifeSciences Corporation, Planisboro NJ, US |
| Decision | Substantially Equivalent, Feb 3, 2006 |
| Received | Dec 30, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053655
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.