K251582
- 510(k) number
- K251582
- Device name
- Redermax Antibacterial Wound Matrix
- Applicant
- Beijing Kreate Medical Co., Ltd. CN
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2026-02-02
- Date received
- 2025-05-23
- 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: K251582.pdf
Official FDA record: K251582
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.