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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 K913771
Device Name ELEGANCE - KED, BEHIND THE EAR HEARING AID
Applicant
QUALITONE
4931 WEST 35TH ST.
MINNEAPOLIS,  MN  55416
Applicant Contact BRUCE BROWN
Correspondent
QUALITONE
4931 WEST 35TH ST.
MINNEAPOLIS,  MN  55416
Correspondent Contact BRUCE BROWN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/22/1991
Decision Date 09/18/1991
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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