510(k) DEN250006
- Device
- Amferia Wound Dressing
- Applicant
- Amferia AB
- 510(k) number
- DEN250006
- Product code
- SHA
- Decision
- Unknown (DENG)
- Decision date
- 2026-02-06
- Date received
- 2025-03-03
- Regulation
- 878.4013
- Classification name
- Solid Wound Dressing With Permanently Bound Antimicrobial Agent
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Anand Rajasekharan
- Address
- C/O Az Bioventurehub Astra Zeneca Pepparedsleden 1 Molndal SE 43183 43183
Source Documents
510(k) summary PDF not indicated by FDA