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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 K955466
Device Name DYNAMEQ-II OPTION
Applicant
Qualitone
4931 W. 35th St.
Minneapolis,  MN  55416
Applicant Contact BRUCE A BROWN
Correspondent
Qualitone
4931 W. 35th St.
Minneapolis,  MN  55416
Correspondent Contact BRUCE A BROWN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/30/1995
Decision Date 02/13/1996
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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