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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleep Appliances With Patient Monitoring
510(k) Number K150369
FOIA Releasable 510(k) K150369
Device Name SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder
Applicant
Somnomed, Inc.
7460 Warren Pkwy. Suite 190
Frisco,  TX  75034
Applicant Contact KIEN T. NGUYEN
Correspondent
Somnomed, Inc.
7460 Warren Pkwy., Suite 190
Frisco,  TX  75035
Correspondent Contact KIEN T. NGUYEN
Regulation Number872.5570
Classification Product Code
PLC  
Date Received02/13/2015
Decision Date 06/18/2015
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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