510(k) K162759 ยท KGN Wound Dressing With Animal-Derived Material(S)
KeraStat(R) Gel
| Applicant | Keranetics, LLC, Winston-Salem NC, US |
| Decision | Substantially Equivalent, Jun 2, 2017 |
| Received | Sep 30, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162759
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.