Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)

Device, Anti-snoring

Meris Investment Group

The following data is part of a premarket notification filed by Meris Investment Group with the FDA for Serena Sleep Block Mandibular Advancement (bma), Serena Sleep Elastic Mandibular Advancement (ema).

Pre-market Notification Details

Device IDK203606
510k NumberK203606
Device Name:Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)
ClassificationDevice, Anti-snoring
Applicant Meris Investment Group 16688 7th Street South Lakeland,  MN  55043
ContactGary Maas
CorrespondentSarah Moss
Medavice, Inc 11218 Zest Ct NE Blaine,  MN  55449
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-10
Decision Date2021-03-10

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