510(k) K201016 ยท FRO Dressing, Wound, Drug
LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)
| Applicant | Huizhou Foryou Medical Devices Co., Ltd., Huizhou, CN |
| Decision | Substantially Equivalent, Jan 28, 2021 |
| Received | Apr 17, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201016
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.