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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 K081965
Device Name MPOWRX SNORING SOLUTION
Applicant
MPOWRX HEALTH AND WELLNESS PRODUCTS INC.
1705 S. CAPITAL OF TEXAS HWY.
SUITE 500
austin,  TX  78746
Applicant Contact jean asquith
Correspondent
MPOWRX HEALTH AND WELLNESS PRODUCTS INC.
1705 S. CAPITAL OF TEXAS HWY.
SUITE 500
austin,  TX  78746
Correspondent Contact jean asquith
Regulation Number872.5570
Classification Product Code
LRK  
Date Received07/10/2008
Decision Date 10/27/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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