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De Novo DEN160037
- Device
- dermaPACE System
- Contact
- peter stegagno
- De Novo number
- DEN160037
- Product code
- PZL
- Regulation
- 878.4685
- Classification name
- extracorporeal shock wave device for treatment of diabetic foot ulcers
- Decision
- granted (DENG)
- Decision date
- 2017-12-28
- Date received
- 2016-07-25
- Classification advisory
- General & Plastic Surgery
- Review advisory
- General & Plastic Surgery
- Type
- Direct
Current FDA Classification#
- Product code
- PZL
- Device name
- Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation
- 878.4685
- Implant
- N
- Life sustain/support
- N