The following data is part of a premarket notification filed by Surgikos, Inc. with the FDA for Barrier & Face Mask With Inner Facing.
| Device ID | K791719 |
| 510k Number | K791719 |
| Device Name: | BARRIER & FACE MASK WITH INNER FACING |
| Classification | Drape, Surgical |
| Applicant | SURGIKOS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-30 |
| Decision Date | 1979-10-04 |