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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 K151719
Device Name REVE134
Applicant
Kw Ear Lab, Inc.
18655 S. Bishop Ave.
Carson,  CA  90746
Applicant Contact Sungwoo Cho
Correspondent
Kw Ear Lab, Inc.
18655 S. Bishop Ave.
Carson,  CA  90746
Correspondent Contact Sungwoo Cho
Regulation Number874.3400
Classification Product Code
KLW  
Date Received06/25/2015
Decision Date 10/09/2015
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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