The following data is part of a premarket notification filed by Foundation For Fluency, Inc. with the FDA for Edinburgh Masker.
| Device ID | K800445 |
| 510k Number | K800445 |
| Device Name: | EDINBURGH MASKER |
| Classification | Device, Anti-stammering |
| Applicant | FOUNDATION FOR FLUENCY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KTH |
| CFR Regulation Number | 874.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-28 |
| Decision Date | 1980-03-12 |