De Novo DEN020001
- Device
- BREASTVIEW VISUAL MAPPING SYSTEM
- Contact
- howard m holstein
- De Novo number
- DEN020001
- Product code
- NKA
- Regulation
- 884.2990
- Classification name
- system, documentation, breast lesion
- Decision
- granted (DENG)
- Decision date
- 2003-01-31
- Date received
- 2002-05-28
- Classification advisory
- Obstetrics/Gynecology
- Review advisory
- Obstetrics/Gynecology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- NKA
- Device name
- System, Documentation, Breast Lesion
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation
- 884.2990
- Implant
- N
- Life sustain/support
- N