510(k) K243181 ยท FRO Dressing, Wound, Drug
Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo
| Applicant | Bionova Medical, Inc., Germantown TN, US |
| Decision | Substantially Equivalent, Oct 31, 2024 |
| Received | Sep 30, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243181
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.