The following data is part of a premarket notification filed by Always More Marketing with the FDA for Zyppah Anti-snoring Device.
Device ID | K182312 |
510k Number | K182312 |
Device Name: | Zyppah Anti-Snoring Device |
Classification | Device, Anti-snoring |
Applicant | Always More Marketing 24981 Palmilla Drive Calabasas, CA 91302 |
Contact | Jonathan Greenburg |
Correspondent | Colette Cozean EyeDeas Company 21581 Midcrest Drive Lake Forest, CA 92630 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-08-27 |
Decision Date | 2019-01-24 |
Summary: | summary |