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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Air-Conduction, Prescription
510(k) Number K905516
Device Name MODEL FT40 TRANSONIC(TM) HEARING AID
Applicant
SONOVATION, INC. DBA AVR SONOVATION
4116 CEDAR AVE.
MINNEAPOLIS,  MN  55407
Applicant Contact WILLIAM KOTHMAN
Correspondent
SONOVATION, INC. DBA AVR SONOVATION
4116 CEDAR AVE.
MINNEAPOLIS,  MN  55407
Correspondent Contact WILLIAM KOTHMAN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/07/1990
Decision Date 04/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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