510(k) K243166 ยท FRO Dressing, Wound, Drug
Dermalage
| Applicant | Infection Elimination Solutions, LLC, Greenville SC, US |
| Decision | Substantially Equivalent, Aug 27, 2025 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243166
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.