The following data is part of a premarket notification filed by Hospitak, Inc. with the FDA for Face Tents.
| Device ID | K781055 |
| 510k Number | K781055 |
| Device Name: | FACE TENTS |
| Classification | Mask, Oxygen |
| Applicant | HOSPITAK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYG |
| CFR Regulation Number | 868.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-23 |
| Decision Date | 1978-07-17 |