FDA 510(k) Application Details - K203606

Device Classification Name Device, Anti-Snoring

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510(K) Number K203606
Device Name Device, Anti-Snoring
Applicant Meris Investment Group
16688 7th Street South
Lakeland, MN 55043 US
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Contact Gary Maas
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 12/10/2020
Decision Date 03/10/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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