510(k) K190528 ยท KGN Wound Dressing With Animal-Derived Material(S)
MariGen Wound Extra
| Applicant | Kerecis Limited, Isafjordur, IS |
| Decision | Substantially Equivalent, Jul 10, 2019 |
| Received | Mar 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190528
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.