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De Novo DEN220006
- Device
- ProdiGI
- Contact
- liron bar yaakov
- De Novo number
- DEN220006
- Product code
- QSW
- Regulation
- 876.4410
- Classification name
- endoscopic traction device
- Decision
- granted (DENG)
- Decision date
- 2022-06-13
- Date received
- 2022-01-14
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- QSW
- Device name
- Endoscopic Traction Device
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.4410
- Implant
- N
- Life sustain/support
- N