The following data is part of a premarket notification filed by Solbaro Co., Ltd with the FDA for Snor Lock.
Device ID | K222475 |
510k Number | K222475 |
Device Name: | SNOR LOCK |
Classification | Device, Anti-snoring |
Applicant | Solbaro Co., Ltd 4th Fl. 137, Janggam-ro Gamgok-myeon, Eumseong-gun, KR 27603 |
Contact | Donghoon Kim |
Correspondent | Jinwook Seo Solbaro Co., Ltd 4th Fl. 137, Janggam-ro Gamgok-myeon, Eumseong-gun, KR 27603 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-08-16 |
Decision Date | 2022-11-10 |