The following data is part of a premarket notification filed by Louis M. Gerson Co., Inc. with the FDA for Surgical Face Mask.
| Device ID | K802373 |
| 510k Number | K802373 |
| Device Name: | SURGICAL FACE MASK |
| Classification | Mask, Surgical |
| Applicant | LOUIS M. GERSON CO., INC. MA |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-29 |
| Decision Date | 1980-11-12 |