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De Novo DEN160040
- Device
- Embosphere Microspheres
- Contact
- alix fonlladosa
- De Novo number
- DEN160040
- Product code
- NOY
- Regulation
- 876.5550
- Classification name
- agents, embolic, for treatment of benign prostatic hyperplasia
- Decision
- granted (DENG)
- Decision date
- 2017-06-21
- Date received
- 2016-08-05
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- NOY
- Device name
- Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.5550
- Implant
- Y
- Life sustain/support
- N