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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 K090503
Device Name ZQUIET MOUTHPIECE
Applicant
SLEEPING WELL, LLC
1468 HARWELL AVE.
crofton,  MD  21114
Applicant Contact yolanda smith
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
northbrook,  IL  60062
Regulation Number872.5570
Classification Product Code
LRK  
Date Received02/25/2009
Decision Date 03/10/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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