510(k) DEN060009
DEN060009 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR". The FDA issued a decision of De Novo Granted on May 8, 2007. The device falls under product code NZJ (Respirator, N95, For Use By The General Public In Public Health Medical Emergencies), a Class II device regulated under 21 CFR 880.6260. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 8, 2007
- Date Received
- October 3, 2006
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
- Device Class
- Class II
- Regulation Number
- 880.6260
- Review Panel
- HO
- Submission Type
It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids.