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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 K971852
Device Name AIR CONDUCTION HAEARING AIDS
Applicant
Beltone Electronics Corp.
4201 W. Victoria St.
Chicago,  IL  60646
Applicant Contact ROBERT A KRATOCHVIL
Correspondent
Beltone Electronics Corp.
4201 W. Victoria St.
Chicago,  IL  60646
Correspondent Contact ROBERT A KRATOCHVIL
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/20/1997
Decision Date 08/15/1997
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
Predetermined Change
Control Plan Authorized		 No
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