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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
Predetermined Change
Control Plan Authorized		 No
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