The following data is part of a premarket notification filed by Louis M. Gerson Co., Inc. with the FDA for Labeling Change To Surgical Face Mask.
| Device ID | K881910 |
| 510k Number | K881910 |
| Device Name: | LABELING CHANGE TO SURGICAL FACE MASK |
| Classification | Mask, Surgical |
| Applicant | LOUIS M. GERSON CO., INC. Middleboro, MA 02346 |
| Contact | Willie Yung |
| Correspondent | Willie Yung LOUIS M. GERSON CO., INC. Middleboro, MA 02346 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-29 |
| Decision Date | 1988-05-18 |