Skip to contentDe Novo DEN250006
- Device
- Amferia Wound Dressing
- Contact
- anand rajasekharan
- De Novo number
- DEN250006
- Product code
- SHA
- Regulation
- 878.4013
- Classification name
- solid wound dressing with permanently bound antimicrobial agent
- Decision
- granted (DENG)
- Decision date
- 2026-02-06
- Date received
- 2025-03-03
- Classification advisory
- General & Plastic Surgery
- Review advisory
- General & Plastic Surgery
- Type
- Direct
Current FDA Classification#
- Product code
- SHA
- Device name
- Solid Wound Dressing With Permanently Bound Antimicrobial Agent
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation
- 878.4013
- Implant
- N
- Life sustain/support
- N