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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,  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
Predetermined Change
Control Plan Authorized		 No
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