K223359 is an FDA 510(k) clearance for the LUOFUCON? Ag+ Foam Dressing, LUOFUCON? Ag+ Antibacterial Foam Dressing, a Dressing, Wound, Drug, submitted by Huizhou Foryou Medical Devices Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on December 21, 2023, 413 days after receiving the submission on November 3, 2022. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K223359 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 03, 2022 |
| Decision Date | December 21, 2023 |
| Days to Decision | 413 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |