Skip to contentDe Novo DEN210049
- Device
- Medline ART Skin Harvesting System
- Contact
- stephanie augsburg
- De Novo number
- DEN210049
- Product code
- QYK
- Regulation
- 878.4795
- Classification name
- semi-automated autologous skin graft harvesting and application device
- Decision
- granted (DENG)
- Decision date
- 2024-03-27
- Date received
- 2021-10-19
- Classification advisory
- General & Plastic Surgery
- Review advisory
- General & Plastic Surgery
- Type
- Direct
Current FDA Classification#
- Product code
- QYK
- Device name
- Semi-Automated Autologous Skin Graft Harvesting And Application Device
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation
- 878.4795
- Implant
- N
- Life sustain/support
- N