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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 K182202
Device Name SLEEPAPP
Applicant
Comfort Acrylics, Inc.
2103 NE 272nd Ave.
Camas,  WA  98607
Applicant Contact Richard W. Moore
Correspondent
Comfort Acrylics, Inc.
2103 NE 272nd Ave.
Camas,  WA  98607
Correspondent Contact Richard W. Moore
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
LQZ  
Date Received08/14/2018
Decision Date 01/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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