De Novo DEN150033
- Device
- Sensor Monitored Alimentary Restriction Therapy (SMART) Device
- Contact
- william longley
- De Novo number
- DEN150033
- Product code
- ONY
- Regulation
- 876.5981
- Classification name
- oral removable retainer for weight management
- Decision
- granted (DENG)
- Decision date
- 2016-09-26
- Date received
- 2015-07-31
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- ONY
- Device name
- Oral Removable Retainer For Weight Management
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.5981
- Implant
- N
- Life sustain/support
- N