De Novo DEN150038
- Device
- CleanCisionTM Wound Retraction and Protection System
- Contact
- lisa ruehlow
- De Novo number
- DEN150038
- Product code
- PQI
- Regulation
- 878.4371
- Classification name
- wound retraction and protection system
- Decision
- granted (DENG)
- Decision date
- 2016-12-16
- Date received
- 2015-08-13
- Classification advisory
- General & Plastic Surgery
- Review advisory
- General & Plastic Surgery
- Type
- Direct
Current FDA Classification#
- Product code
- PQI
- Device name
- Wound Retraction And Protection System
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation
- 878.4371
- Implant
- N
- Life sustain/support
- N