Clearance Summary
3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR received FDA 510(k) clearance under submission number DEN060009, sponsored by 3M Company. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2007-05-08.
- Submission: DEN060009
- Applicant / Sponsor: 3M Company
- Clearance pathway: Post-NSE
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6260
- Decision date: 2007-05-08
Classification & Regulation
This clearance is catalogued under FDA product code NZJ and 21 CFR 880.6260, within the General Hospital review panel as a Class II device.