The following data is part of a premarket notification filed by American Optical Corp. with the FDA for Ao Flexible Laryngoscope, #ls-7.
| Device ID | K802331 |
| 510k Number | K802331 |
| Device Name: | AO FLEXIBLE LARYNGOSCOPE, #LS-7 |
| Classification | Laryngoscope, Non-rigid |
| Applicant | AMERICAN OPTICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAL |
| CFR Regulation Number | 868.5530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-23 |
| Decision Date | 1980-10-10 |