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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 K902570
Device Name ADAM MARK II CUSTOM IN-THE-EAR HEARING AID
Applicant
Adams Hearing Aid Center
5219 W. Clearwater
Suite 1a
Kennewick,  WA  99336
Applicant Contact ARLEN H ADAMS
Correspondent
Adams Hearing Aid Center
5219 W. Clearwater
Suite 1a
Kennewick,  WA  99336
Correspondent Contact ARLEN H ADAMS
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/08/1990
Decision Date 07/09/1990
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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