The following data is part of a premarket notification filed by Distar, Inc. with the FDA for Adjustable Therasnore.
| Device ID | K973038 |
| 510k Number | K973038 |
| Device Name: | ADJUSTABLE THERASNORE |
| Classification | Device, Anti-snoring |
| Applicant | DISTAR, INC. 214 WEST CORK ST. Winchester, VA 22601 -4136 |
| Contact | Stephen A Brown |
| Correspondent | Stephen A Brown DISTAR, INC. 214 WEST CORK ST. Winchester, VA 22601 -4136 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-14 |
| Decision Date | 1997-11-12 |