Amferia Wound Dressing
FDA 510(k) clearance DEN250006 · decided 2026-02-06
Clearance details
- K-number
- DEN250006
- Device name
- Amferia Wound Dressing
- Applicant
- Amferia AB
- Decision
- Unknown
- Date received
- 2025-03-03
- Decision date
- 2026-02-06
- Days to decision
- 340 days
- Clearance type
- Direct
- Product code
- SHA
- Device class
- 2
- Regulation number
- 878.4013
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Molndal, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.