The following data is part of a premarket notification filed by Irema Usa Ltd. with the FDA for Disposable Surgical Face Masks.
| Device ID | K812675 |
| 510k Number | K812675 |
| Device Name: | DISPOSABLE SURGICAL FACE MASKS |
| Classification | Mask, Surgical |
| Applicant | IREMA USA LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-22 |
| Decision Date | 1981-10-13 |