The following data is part of a premarket notification filed by Insert Molding Solutions, Inc. with the FDA for Rest Eazy Appliance.
| Device ID | K172760 |
| 510k Number | K172760 |
| Device Name: | REST EAZY Appliance |
| Classification | Device, Anti-snoring |
| Applicant | Insert Molding Solutions, Inc. 4325 Settingdown Circle, Suite 103 Cumming, GA 30028 |
| Contact | Paul Hendrixson |
| Correspondent | Felicia Ruley Regulatory And Quality Solutions, LLC 2790 Mosside Blvd #800 Monroeville, PA 15146 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-13 |
| Decision Date | 2018-03-26 |
| Summary: | summary |