De Novo DEN160005
- Device
- Hem-Avert Perianal Stabilizer
- Contact
- mark buchanan
- De Novo number
- DEN160005
- Product code
- PNU
- Regulation
- 884.5210
- Classification name
- pressure wedge, perianal, for reduction of cesarean delivery
- Decision
- granted (DENG)
- Decision date
- 2016-12-19
- Date received
- 2016-01-28
- Classification advisory
- Obstetrics/Gynecology
- Review advisory
- Obstetrics/Gynecology
- Type
- Direct
Current FDA Classification#
- Product code
- PNU
- Device name
- Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation
- 884.5210
- Implant
- N
- Life sustain/support
- N