The following data is part of a premarket notification filed by Surgikos, Inc. with the FDA for Surgikos Face Mask.
| Device ID | K810316 |
| 510k Number | K810316 |
| Device Name: | SURGIKOS FACE MASK |
| Classification | Mask, Surgical |
| Applicant | SURGIKOS, INC. 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 | 1981-02-06 |
| Decision Date | 1981-02-23 |