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De Novo DEN060009
- Device
- 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR
- Contact
- dianne gibbs
- De Novo number
- DEN060009
- Product code
- NZJ
- Regulation
- 880.6260
- Classification name
- respirator, n95, for use by the general public in public health medical emergencies
- Decision
- granted (DENG)
- Decision date
- 2007-05-08
- Date received
- 2006-10-03
- Classification advisory
- General Hospital
- Review advisory
- General Hospital
- Type
- Post-NSE
Current FDA Classification#
- Product code
- NZJ
- Device name
- Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation
- 880.6260
- Implant
- N
- Life sustain/support
- N