510(k) K191992 ยท KGN Wound Dressing With Animal-Derived Material(S)
PELNAC Bilayer Wound Matrix
| Applicant | Gunze Limited, Ayabe, Kyoto, JP |
| Decision | Substantially Equivalent, Apr 29, 2020 |
| Received | Jul 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191992
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.