K240485
- 510(k) number
- K240485
- Device name
- LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)
- Applicant
- Huizhou Foryou Medical Devices Co., Ltd. CN
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2024-10-07
- Date received
- 2024-02-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K240485.pdf
Official FDA record: K240485
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.