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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Prescription
510(k) Number K230495
Device Name Serena Sleep Night Guard
Applicant
Meris Investment Group
1145 Quentin Ave S
Lakeland,  MN  55043
Applicant Contact Gary Maas
Correspondent
Prime Path Medtech
811 Lakeview Dr.
Shoreview,  MN  55126
Correspondent Contact Janice Farris
Classification Product Code
MQC  
Subsequent Product Code
OCO  
Date Received02/23/2023
Decision Date 10/13/2023
Decision Substantially Equivalent (SESE)
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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