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De Novo DEN190042
- Device
- Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
- Contact
- kristen bozzelli
- De Novo number
- DEN190042
- Product code
- QAX
- Regulation
- 876.5862
- Classification name
- hemodialyzer with expanded solute removal profile
- Decision
- granted (DENG)
- Decision date
- 2020-08-28
- Date received
- 2019-09-16
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- QAX
- Device name
- Hemodialyzer With Expanded Solute Removal Profile
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.5862
- Implant
- N
- Life sustain/support
- Y