K221110
- 510(k) number
- K221110
- Device name
- LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing
- Applicant
- Huizhou Foryou Medical Devices Co., Ltd. CN
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2024-01-04
- Date received
- 2022-04-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K221110.pdf
Official FDA record: K221110
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.