De Novo DEN150008
- Device
- INVOcell
- Contact
- kathleen karloff
- De Novo number
- DEN150008
- Product code
- OYO
- Regulation
- 884.6165
- Classification name
- culture, intravaginal, assisted reproduction
- Decision
- granted (DENG)
- Decision date
- 2015-11-02
- Date received
- 2015-02-23
- Classification advisory
- Obstetrics/Gynecology
- Review advisory
- Obstetrics/Gynecology
- Type
- Direct
Current FDA Classification#
- Product code
- OYO
- Device name
- Culture, Intravaginal, Assisted Reproduction
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation
- 884.6165
- Implant
- N
- Life sustain/support
- N