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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 K163094
Device Name TinniLogic Mobile Tinnitus Management Device
Applicant
Jiangsu Betterlife Medical Co., Ltd.
#11 Si Hai Rd., Changshu Economic And Technical
Development Park
Changshu,  CN 215513
Applicant Contact HONGWEI XU
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact DIANA HONG
Regulation Number874.3400
Classification Product Code
KLW  
Date Received11/04/2016
Decision Date 05/17/2017
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
Predetermined Change
Control Plan Authorized		 No
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