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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 K122475
Device Name ZQUIET PRO-PLUS
Applicant
SLEEPING WELL, LLC
5247 Shelburne Rd Ste 204
Shelburne,  VT  05482
Applicant Contact DANIEL WEBSTER
Correspondent
SLEEPING WELL, LLC
5247 Shelburne Rd Ste 204
Shelburne,  VT  05482
Correspondent Contact DANIEL WEBSTER
Regulation Number872.5570
Classification Product Code
LRK  
Date Received08/14/2012
Decision Date 12/07/2012
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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