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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 K140777
Device Name ZQUIET-SA
Applicant
SLEEPING WELL, LLC
342 E. MAIN STREET, STE 207
LEOLA,  PA  17540
Applicant Contact WILLIAM MCLAIN
Correspondent
SLEEPING WELL, LLC
342 E. MAIN STREET, STE 207
LEOLA,  PA  17540
Correspondent Contact WILLIAM MCLAIN
Regulation Number872.5570
Classification Product Code
LRK  
Date Received03/28/2014
Decision Date 07/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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