The following data is part of a premarket notification filed by Michael D Williams Dds Pa with the FDA for Sleeptight Mouthpiece Stz.
| Device ID | K191618 |
| 510k Number | K191618 |
| Device Name: | SleepTight Mouthpiece STZ |
| Classification | Device, Anti-snoring |
| Applicant | Michael D Williams DDS PA 10991 SW 42ND PL Davie, FL 33328 |
| Contact | Michael Williams |
| Correspondent | Michael Williams Michael D Williams DDS PA 10991 SW 42ND PL Davie, FL 33328 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-18 |
| Decision Date | 2019-12-11 |