The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Brand Ear Loop Face Mask, 2000f.
| Device ID | K910182 |
| 510k Number | K910182 |
| Device Name: | 3M BRAND EAR LOOP FACE MASK, 2000F |
| Classification | Mask, Surgical |
| Applicant | 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul, MN 55144 -1000 |
| Contact | Paul A Burgio |
| Correspondent | Paul A Burgio 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul, MN 55144 -1000 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-15 |
| Decision Date | 1991-03-04 |