510(k) K213231 ยท KGN Wound Dressing With Animal-Derived Material(S)
Kerecis Silicone
| Applicant | Kerecis Limited, Isafjordur, IS |
| Decision | Substantially Equivalent, Jun 29, 2022 |
| Received | Sep 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213231
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.