The following data is part of a premarket notification filed by Michael D. Williams,dds Pa with the FDA for Sleeptight Mouthpiece, Sleeppro, Quietnite, Altitude Mouthpiece, Sleep Easy.
| Device ID | K132506 |
| 510k Number | K132506 |
| Device Name: | SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY |
| Classification | Device, Anti-snoring |
| Applicant | MICHAEL D. WILLIAMS,DDS PA 10991 SW 42ND PL Davie, FL 33328 |
| Contact | Michael D Williams |
| Correspondent | Michael D 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 | 2013-08-12 |
| Decision Date | 2014-05-29 |