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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name masker, tinnitus
510(k) Number K161331
Device Name HyperSound Tinnitus Module
Applicant
TURTLE BEACH CORPORATION
12220 SCRIPPS SUMMIT DRIVE, SUITE 100
SAN DIEGO,  CA  92131
Applicant Contact JAMES A. BARNES
Correspondent
TURTLE BEACH CORPORATION
12220 SCRIPPS SUMMIT DRIVE, SUITE 100
SAN DIEGO,  CA  92131
Correspondent Contact JAMES A. BARNES
Regulation Number874.3400
Classification Product Code
KLW  
Date Received05/12/2016
Decision Date 08/23/2016
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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