De Novo DEN220078
- Device
- Eroxon
- Contact
- rachael hawken
- De Novo number
- DEN220078
- Product code
- QWW
- Regulation
- 876.5021
- Classification name
- non-medicated topical formulation for treatment of erectile dysfunction.
- Decision
- granted (DENG)
- Decision date
- 2023-06-09
- Date received
- 2022-10-21
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- QWW
- Device name
- Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.5021
- Implant
- N
- Life sustain/support
- N