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 |