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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 K150014
Device Name Serenity
Applicant
SANUTHERA, INC.
340 WEST STATE STREET, UNIT 45
ATHENS,  OH  45701
Applicant Contact JEFFERY DIGIOVANNI
Correspondent
SANUTHERA, INC.
340 WEST STATE STREET, UNIT 45
ATHENS,  OH  45701
Correspondent Contact JEFFERY DIGIOVANNI
Regulation Number874.3400
Classification Product Code
KLW  
Date Received01/05/2015
Decision Date 07/27/2015
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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