510(k) K253204 ยท KGN Wound Dressing With Animal-Derived Material(S)
Catalyze
| Applicant | BioTissue Holdings, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jun 5, 2026 |
| Received | Sep 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253204
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.