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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 K132506
Device Name SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY
Applicant
MICHAEL D. WILLIAMS,DDS PA
10991 sw 42nd pl
davie,  FL  33328
Applicant Contact michael d williams
Correspondent
MICHAEL D. WILLIAMS,DDS PA
10991 sw 42nd pl
davie,  FL  33328
Correspondent Contact michael d williams
Regulation Number872.5570
Classification Product Code
LRK  
Date Received08/12/2013
Decision Date 05/29/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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