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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 K213088
Device Name ZQuiet Advance
Applicant
Sleeping Well, LLC
138 Steeplebush Rd.
Shelburne,  VT  05482
Applicant Contact Daniel Webster
Correspondent
Keystone Regulatory Services, LLC
342 E. Main St.
Suite 207
Leola,  PA  17540
Correspondent Contact William McLain
Regulation Number872.5570
Classification Product Code
LRK  
Date Received09/24/2021
Decision Date 06/15/2022
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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