The following data is part of a premarket notification filed by 3m Health Care with the FDA for 3m High Performance Surgical Mask, 3m High Performance Surgical Mask With Face Shield.
| Device ID | K180874 |
| 510k Number | K180874 |
| Device Name: | 3M High Performance Surgical Mask, 3M High Performance Surgical Mask With Face Shield |
| Classification | Mask, Surgical |
| Applicant | 3M Health Care 3M Center, 2510 Conway Ave, Building 275-5W-06 St. Paul, MN 55144 |
| Contact | Linda Johnsen |
| Correspondent | Kristin Totushek 3M Health Care 3M Health Care 2510 Conway Ave, Building 275-5W-06 St. Paul, MN 55144 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-03 |
| Decision Date | 2018-07-31 |
| Summary: | summary |