DEN250006
- 510(k) number
- DEN250006
- Device name
- Amferia Wound Dressing
- Applicant
- Amferia AB SE
- Product code
- SHA — Solid Wound Dressing With Permanently Bound Antimicr
- Decision date
- 2026-02-06
- Date received
- 2025-03-03
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- General, Plastic Surgery
Official FDA record: DEN250006
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.