510(k) K221755 ยท FRO Dressing, Wound, Drug
Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing
| Applicant | Winner Medical Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jan 13, 2023 |
| Received | Jun 16, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K221755
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.