The following data is part of a premarket notification filed by Sleeping Well, Llc with the FDA for Zquiet Mouthpiece.
| Device ID | K090503 |
| 510k Number | K090503 |
| Device Name: | ZQUIET MOUTHPIECE |
| Classification | Device, Anti-snoring |
| Applicant | SLEEPING WELL, LLC 1468 HARWELL AVE. Crofton, MD 21114 |
| Contact | Yolanda Smith |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-02-25 |
| Decision Date | 2009-03-10 |
| Summary: | summary |