The following data is part of a premarket notification filed by Greystone Ip Ltd with the FDA for Soundly Anti Snoring Device.
Device ID | K220330 |
510k Number | K220330 |
Device Name: | Soundly Anti Snoring Device |
Classification | Device, Anti-snoring |
Applicant | Greystone IP Ltd Unit 322, Moat House, 54 Bloomfield Avenue Belfast, IE BT5 5AD |
Contact | Judy Purvis |
Correspondent | Judy Purvis Greystone IP Ltd Unit 322, Moat House, 54 Bloomfield Avenue Belfast, IE BT5 5AD |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-02-04 |
Decision Date | 2022-09-08 |