K232796 is an FDA 510(k) clearance for the LUOFUCON® Collagen Particles (Collagen Wound Dressing). This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Huizhou Foryou Medical Devices Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on April 25, 2024, 226 days after receiving the submission on September 12, 2023.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K232796 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2023 |
| Decision Date | April 25, 2024 |
| Days to Decision | 226 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGN — Wound Dressing With Animal-derived Material(s) |
| Device Class | — |