510(k) K181315 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, Feb 14, 2019 |
| Received | May 18, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181315
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.