510(k) DEN220078
- Device
- Eroxon
- Applicant
- Futura Medical Developments Limited
- 510(k) number
- DEN220078
- Product code
- QWW
- Decision
- Unknown (DENG)
- Decision date
- 2023-06-09
- Date received
- 2022-10-21
- Regulation
- 876.5021
- Classification name
- Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Rachael Hawken
- Address
- The Surrey Technology Centre 40 Occam Rd., Surrey Research Park Guildford GB GU2 7YG GU2 7YG
FDA Registration Numbers#
- 3010041486
- 3003592318
- 3003491851
- 3012293198
- 3010166945
Source Documents#
510(k) summary PDF not indicated by FDA