510(k) K213498 ยท KGN Wound Dressing With Animal-Derived Material(S)
PELNAC Meshed Bilayer Wound Matrix
| Applicant | Gunze Limited, Ayabe, Kyoto, JP |
| Decision | Substantially Equivalent, Jul 14, 2022 |
| Received | Nov 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213498
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.