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De Novo DEN220087
- Device
- Edison System
- Contact
- daniel kosednar
- De Novo number
- DEN220087
- Product code
- QGM
- Regulation
- 878.4405
- Classification name
- focused ultrasound system for non-thermal, mechanical tissue ablation
- Decision
- granted (DENG)
- Decision date
- 2023-10-06
- Date received
- 2022-12-02
- Classification advisory
- General & Plastic Surgery
- Review advisory
- General & Plastic Surgery
- Type
- Direct
Current FDA Classification#
- Product code
- QGM
- Device name
- Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation
- 878.4405
- Implant
- N
- Life sustain/support
- N