The following data is part of a De Novo classification by 3m Company with the FDA for 3m N95 Home Respirator With Fluid Resistance; 3m N95 Home Respirator.
| DeNovo ID | DEN060009 |
| Device Name: | 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR |
| Classification | Respirator, N95, For Use By The General Public In Public Health Medical Emergencies |
| Applicant | 3M COMPANY 3m Center, Bldg. 275-5w-06 St. Paul, MN 55144 -1000 |
| Contact | Dianne Gibbs |
| Product Code | NZJ |
| CFR Regulation Number | 880.6260 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K062070 |
| Review Advisory Board | General Hospital |
| Classification Advisory | General Hospital |
| Type | Post-NSE |
| Date Received | 2006-10-03 |
| Decision Date | 2007-05-08 |
| Reclassification Order: | Reclassification Order |