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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 K941107
Device Name THE CANAL (C.I.C.) AKA/HIDDEN EAR
Applicant
Qualitone, Inc.
4931 W. 35th St.
Minneapolis,  MN  55416
Applicant Contact BRUCE BROWN
Correspondent
Qualitone, Inc.
4931 W. 35th St.
Minneapolis,  MN  55416
Correspondent Contact BRUCE BROWN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/07/1994
Decision Date 08/09/1994
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
Predetermined Change
Control Plan Authorized		 No
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