The following data is part of a premarket notification filed by Lear Corporation with the FDA for Surgical Face Mask, Surgical Mask.
| Device ID | K201844 |
| 510k Number | K201844 |
| Device Name: | Surgical Face Mask, Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Lear Corporation 1 Penn Dye St Pine Grove, PA 17963 |
| Contact | Ryan Facer |
| Correspondent | Ryan Facer Lear Corporation 1 Penn Dye St Pine Grove, PA 17963 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-06 |
| Decision Date | 2021-07-14 |