510(k) K161278 ยท GXQ Dura Substitute
Cerafix Dura Substitute
| Applicant | Acera Surgical, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Aug 8, 2016 |
| Received | May 6, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161278
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.