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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 DRIVE, STE 285
ST. LOUIS,  MO  63131
Applicant Contact LEAH AMIR, MS, MHA
Correspondent
INSTITUTE FOR QUALITY RESOURCE MANAGEMENT
1 CITY PLACE DRIVE, STE 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
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