The following data is part of a premarket notification filed by Surgikos, Inc. with the FDA for Surgine Face Mask.
| Device ID | K760991 |
| 510k Number | K760991 |
| Device Name: | SURGINE FACE MASK |
| Classification | Mask, Surgical |
| Applicant | SURGIKOS, INC. MD |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-11-05 |
| Decision Date | 1976-11-16 |