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 |