510(k) K192463 ยท FRO Dressing, Wound, Drug
PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border
| Applicant | Winner Medical Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, May 14, 2020 |
| Received | Sep 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192463
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.