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De Novo DEN180060
- Device
- Plenity
- Contact
- eyal ron
- De Novo number
- DEN180060
- Product code
- QFQ
- Regulation
- 876.5982
- Classification name
- ingested, transient, space occupying device for weight management and/or weight loss
- Decision
- granted (DENG)
- Decision date
- 2019-04-12
- Date received
- 2018-11-15
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- QFQ
- Device name
- Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.5982
- Implant
- N
- Life sustain/support
- N