510(k) DEN060009
- Device
- 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR
- Applicant
- 3M Company
- 510(k) number
- DEN060009
- Product code
- NZJ
- Decision
- Unknown (DENG)
- Decision date
- 2007-05-08
- Date received
- 2006-10-03
- Regulation
- 880.6260
- Classification name
- Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- DIANNE GIBBS
- Address
- 3m Center, Bldg. 275-5w-06 St. Paul MN US 55144 55144
FDA Registration Numbers#
- 3010141571
- 3016678387
- 2110898
- 3005236311
- 3008048818
- 3015997711
- 3006942307
- 3012104670
- 3008770708
- 3011310668
- 2427500
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NZJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K083176 | PASTURE, MODELS: F550, A520 | Pasture Pharma Pte, Ltd. | 2009-01-23 |