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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 K193239
Device Name MPowRx Snoring Solution (also known as Good Morning Snore Solution)
Applicant
MPowRx Health and Wellness Products 2012 Inc
# 510 3553-31 St. NW
Calgary,  CA T2L2K7
Applicant Contact Nancy Markley
Correspondent
Arazy Group Consultants Inc.
3422 Leonardo Lane
New Smyrna Beach,  FL  32168
Correspondent Contact Ray Kelly
Regulation Number872.5570
Classification Product Code
LRK  
Date Received11/25/2019
Decision Date 01/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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