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De Novo DEN110002
- Device
- SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT
- Contact
- robert sullivan
- De Novo number
- DEN110002
- Product code
- OVY
- Regulation
- 880.6887
- Classification name
- liquid chemical processing system
- Decision
- granted (DENG)
- Decision date
- 2012-03-30
- Date received
- 2011-08-01
- Classification advisory
- General Hospital
- Review advisory
- General Hospital
- Type
- Post-NSE
Current FDA Classification#
- Product code
- OVY
- Device name
- Liquid Chemical Processing System
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation
- 880.6887
- Implant
- N
- Life sustain/support
- N