The following data is part of a premarket notification filed by Glidewell Laboratories with the FDA for Silentnite.
| Device ID | K972424 |
| 510k Number | K972424 |
| Device Name: | SILENTNITE |
| Classification | Device, Anti-snoring |
| Applicant | GLIDEWELL LABORATORIES 4141 MACARTHUR BLVD. Newport Beach, CA 92660 |
| Contact | Keith D Allred |
| Correspondent | Keith D Allred GLIDEWELL LABORATORIES 4141 MACARTHUR BLVD. Newport Beach, CA 92660 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-27 |
| Decision Date | 1997-09-18 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SILENTNITE 75692423 2496802 Dead/Cancelled |
O'Donnell, Francis E. Jr. 1999-04-26 |