510(k) K190819 ยท FRO Dressing, Wound, Drug
Silicone PHMB Foam Wound Dressing
| Applicant | Advanced Medical Solutions, Ltd., Winsford, GB |
| Decision | Substantially Equivalent, Jul 25, 2019 |
| Received | Apr 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190819
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.