The following data is part of a premarket notification filed by 3m Health Care with the FDA for 3m™ High Fluid-resistant Surgical Mask And 3m™ High Fluid-resistant Procedure Mask.
| Device ID | K191355 |
| 510k Number | K191355 |
| Device Name: | 3M™ High Fluid-Resistant Surgical Mask And 3M™ High Fluid-Resistant Procedure Mask |
| Classification | Mask, Surgical |
| Applicant | 3M Health Care 3M Center, 2510 Conway Ave., Building 275-5W-06 St. Paul, MN 55144 |
| Contact | Angie Draper |
| Correspondent | Angie Draper 3M Health Care 3M Center, 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 | 2019-05-21 |
| Decision Date | 2019-09-11 |
| Summary: | summary |