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 |