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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 K203606
Device Name Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)
Applicant
Meris Investment Group
16688 7th St. S.
Lakeland,  MN  55043
Applicant Contact Gary Maas
Correspondent
Medavice, Inc.
11218 Zest Ct NE
Blaine,  MN  55449
Correspondent Contact Sarah Moss
Regulation Number872.5570
Classification Product Code
LRK  
Date Received12/10/2020
Decision Date 03/10/2021
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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