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510(k) K201484

Somnos Anti-Snoring Mouth Guard by Koncept Innovators, LLC — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2020
Date Received
June 4, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Anti-Snoring
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

Other clearances by Koncept Innovators, LLC

  • K181099 — Bright Guard (January 18, 2019)

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