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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.
NO.11 SI HAI ROAD, 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
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