The following data is part of a premarket notification filed by Comfort Acrylics, Inc. with the FDA for Sleepapp.
| Device ID | K182202 |
| 510k Number | K182202 |
| Device Name: | SLEEPAPP |
| Classification | Device, Anti-snoring |
| Applicant | Comfort Acrylics, Inc. 2103 NE 272nd Ave. Camas, WA 98607 |
| Contact | Richard W. Moore |
| Correspondent | Richard W. Moore Comfort Acrylics, Inc. 2103 NE 272nd Ave. Camas, WA 98607 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-14 |
| Decision Date | 2019-01-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SLEEPAPP 77939269 3982335 Live/Registered |
Richard W. Moore, DDS, PC 2010-02-18 |
![]() SLEEPAPP 77939265 3982334 Live/Registered |
Richard W. Moore, DDS, PC 2010-02-18 |