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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 K181123
Device Name ApnoDent Appliance
Applicant
Apnomed, Inc.
1515 116th Ave. NE, Suite 105c
Bellevue,  WA  98004
Applicant Contact Joseph Yousefian
Correspondent
Dr. Colette Cozean, PHD
21581 Midcrest Dr.
Lake Forest,  CA  92630
Correspondent Contact Colette Cozean
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
LQZ  
Date Received04/30/2018
Decision Date 11/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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