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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Group And Auditory Trainer
510(k) Number K133352
Device Name HYPERSOUND AUDIO SYSTEM (HSS)
Applicant
HYPERSOUND HEALTH, INC.
13771 DANIELSON ST. STE. L
POWAY,  CA  92064
Applicant Contact JAMES A BARNES
Correspondent
HYPERSOUND HEALTH, INC.
13771 DANIELSON ST. STE. L
POWAY,  CA  92064
Correspondent Contact JAMES A BARNES
Regulation Number874.3320
Classification Product Code
EPF  
Date Received10/31/2013
Decision Date 02/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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