K242856
- 510(k) number
- K242856
- Device name
- LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)
- Applicant
- Huizhou Foryou Medical Devices Co., Ltd. CN
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2024-11-13
- Date received
- 2024-09-20
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242856.pdf
Official FDA record: K242856
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.