Skip to contentDe Novo DEN090011
- Device
- HEM-AVERT PERIANAL STABILIZER
- Contact
- david blurton
- De Novo number
- DEN090011
- Product code
- OOA
- Regulation
- 884.5200
- Classification name
- hemorrhoid prevention pressure wedge
- Decision
- granted (DENG)
- Decision date
- 2011-01-13
- Date received
- 2009-08-18
- Classification advisory
- Obstetrics/Gynecology
- Review advisory
- Obstetrics/Gynecology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- OOA
- Device name
- Hemorrhoid Prevention Pressure Wedge
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation
- 884.5200
- Implant
- N
- Life sustain/support
- N