510(k) K111946 ยท OOD Surgical Film
TEPHAFLEX MESH
| Applicant | Tepha, Inc., Lexington MA, US |
| Decision | Substantially Equivalent, Sep 26, 2011 |
| Received | Jul 8, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111946
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.