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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 K191618
Device Name SleepTight Mouthpiece STZ
Applicant
Michael D Williams Dds PA
10991 SW 42nd Pl.
Davie,  FL  33328
Applicant Contact Michael Williams
Correspondent
Michael D Williams Dds PA
10991 SW 42nd Pl.
Davie,  FL  33328
Correspondent Contact Michael Williams
Regulation Number872.5570
Classification Product Code
LRK  
Date Received06/18/2019
Decision Date 12/11/2019
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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