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De Novo DEN220082
- Device
- Breast Implant Removal Device (BIRD)
- Contact
- alex cerveniak
- De Novo number
- DEN220082
- Product code
- QVS
- Regulation
- 878.4675
- Classification name
- breast implant suction retrieval device
- Decision
- granted (DENG)
- Decision date
- 2023-04-20
- Date received
- 2022-11-21
- Classification advisory
- General & Plastic Surgery
- Review advisory
- General & Plastic Surgery
- Type
- Direct
Current FDA Classification#
- Product code
- QVS
- Device name
- Breast Implant Suction Retrieval Device
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation
- 878.4675
- Implant
- N
- Life sustain/support
- N