K201016 is an FDA 510(k) clearance for the LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use). This device is classified as a Dressing, Wound, Drug.
Submitted by Huizhou Foryou Medical Devices Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on January 28, 2021, 286 days after receiving the submission on April 17, 2020.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K201016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2020 |
| Decision Date | January 28, 2021 |
| Days to Decision | 286 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |