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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 K133390
Device Name NDX DORSAL APPLIANCE
Applicant
Institute For Quality Resource Management
1 City Place Dr., Suite 285
St. Louis,  MO  63131
Applicant Contact LEAH AMIR, MS, MHA
Correspondent
Institute For Quality Resource Management
1 City Place Dr., Suite 285
St. Louis,  MO  63131
Correspondent Contact LEAH AMIR, MS, MHA
Regulation Number872.5570
Classification Product Code
LRK  
Date Received11/05/2013
Decision Date 10/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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