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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, anti-snoring
510(k) Number K182312
Device Name Zyppah Anti-Snoring Device
Applicant
Always More Marketing
24981 Palmilla Drive
Calabasas,  CA  91302
Applicant Contact Jonathan Greenburg
Correspondent
EyeDeas Company
21581 Midcrest Drive
Lake Forest,  CA  92630
Correspondent Contact Colette Cozean
Regulation Number872.5570
Classification Product Code
LRK  
Date Received08/27/2018
Decision Date 01/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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