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De Novo DEN020003
- Device
- RETROX
- Contact
- david j navaroli
- De Novo number
- DEN020003
- Product code
- NIX
- Regulation
- 874.3950
- Classification name
- hearing aid, air conduction, transcutaneous system
- Decision
- granted (DENG)
- Decision date
- 2002-08-20
- Date received
- 2002-06-21
- Classification advisory
- Ear Nose & Throat
- Review advisory
- Ear Nose & Throat
- Type
- Post-NSE
Current FDA Classification#
- Product code
- NIX
- Device name
- Hearing Aid, Air Conduction, Transcutaneous System
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation
- 874.3950
- Implant
- Y
- Life sustain/support
- N