The following data is part of a premarket notification filed by Vesta, Inc. with the FDA for Silicone Rubber-bi Nasopharyngeal Air.
| Device ID | K792018 |
| 510k Number | K792018 |
| Device Name: | SILICONE RUBBER-BI NASOPHARYNGEAL AIR |
| Classification | Airway, Nasopharyngeal |
| Applicant | VESTA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTQ |
| CFR Regulation Number | 868.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-09 |
| Decision Date | 1979-11-13 |