De Novo DEN150001
- Device
- RELIZORB
- Contact
- robert gallotto
- De Novo number
- DEN150001
- Product code
- PLQ
- Regulation
- 876.5985
- Classification name
- enzyme packed cartridge
- Decision
- granted (DENG)
- Decision date
- 2015-11-20
- Date received
- 2015-01-02
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- PLQ
- Device name
- Enzyme Packed Cartridge
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.5985
- Implant
- N
- Life sustain/support
- N