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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 K961827
Device Name IN-THE-EAR
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 Received05/13/1996
Decision Date 07/03/1996
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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