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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 K092942
Device Name VITAL SLEEP
Applicant
THE SNORE RELIEVER COMPANY LLC
28711 JAEGER DRIVE
LAGUNA NIGUEL,  CA  92677
Applicant Contact NICOLAAS BESSELING
Correspondent
THE SNORE RELIEVER COMPANY LLC
28711 JAEGER DRIVE
LAGUNA NIGUEL,  CA  92677
Correspondent Contact NICOLAAS BESSELING
Regulation Number872.5570
Classification Product Code
LRK  
Date Received09/24/2009
Decision Date 01/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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