K231057
- 510(k) number
- K231057
- Device name
- Antibacterial Gel Wound Dressing
- Applicant
- Winner Medical Co., Ltd. CN
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2023-12-01
- Date received
- 2023-04-13
- 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: K231057.pdf
Official FDA record: K231057
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.