The following data is part of a premarket notification filed by Sleeping Well, Llc with the FDA for Zquiet Mouthpiece.
| Device ID | K093407 |
| 510k Number | K093407 |
| Device Name: | ZQUIET MOUTHPIECE |
| Classification | Device, Anti-snoring |
| Applicant | SLEEPING WELL, LLC 1468 HARWELL AVE. Crofton, MD 21114 |
| Contact | Yolanda Smith |
| Correspondent | Yolanda Smith SLEEPING WELL, LLC 1468 HARWELL AVE. Crofton, MD 21114 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-02 |
| Decision Date | 2010-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858522003173 | K093407 | 000 |