The following data is part of a premarket notification filed by Sleeping Well, Llc with the FDA for Zquiet-sa.
| Device ID | K140777 |
| 510k Number | K140777 |
| Device Name: | ZQUIET-SA |
| Classification | Device, Anti-snoring |
| Applicant | SLEEPING WELL, LLC 342 E. MAIN STREET, STE 207 Leola, PA 17540 |
| Contact | William Mclain |
| Correspondent | William Mclain SLEEPING WELL, LLC 342 E. MAIN STREET, STE 207 Leola, PA 17540 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-28 |
| Decision Date | 2014-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858522003289 | K140777 | 000 |
| 00858522003265 | K140777 | 000 |
| 00858522003258 | K140777 | 000 |
| 00858522003241 | K140777 | 000 |
| 00858522003234 | K140777 | 000 |
| 00858522003227 | K140777 | 000 |