510(k) K162922 ยท OOD Surgical Film
GalaFORM 3D
| Applicant | Tepha, Inc., Lexington MA, US |
| Decision | Substantially Equivalent, Feb 23, 2017 |
| Received | Oct 18, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162922
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.