The following data is part of a premarket notification filed by Kells Medical, Inc. with the FDA for Say.
| Device ID | K823118 |
| 510k Number | K823118 |
| Device Name: | SAY |
| Classification | Larynx, Artificial (battery-powered) |
| Applicant | KELLS MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ESE |
| CFR Regulation Number | 874.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-21 |
| Decision Date | 1983-01-07 |