510(k) K210949 ยท KGN Wound Dressing With Animal-Derived Material(S)
Foundation Dermal Regeneration Scaffold (DRS) Solo
| Applicant | Bionova Medical, Inc., Germantown TN, US |
| Decision | Substantially Equivalent, Aug 11, 2022 |
| Received | Mar 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210949
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.