The following data is part of a premarket notification filed by Harvard Laboratories with the FDA for Disposable Berman Airways.
| Device ID | K800881 |
| 510k Number | K800881 |
| Device Name: | DISPOSABLE BERMAN AIRWAYS |
| Classification | Airway, Oropharyngeal, Anesthesiology |
| Applicant | HARVARD LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAE |
| CFR Regulation Number | 868.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-17 |
| Decision Date | 1980-05-08 |