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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 K851547
Device Name BEHIND THE EAR HEARING AID MODEL BERNAFON T-82
Applicant
Bernafon, Inc.
1125 Globe Ave.
P.O. Box 1160
Mountainside,  NJ  07092
Applicant Contact TED MIKSIEWICZ
Correspondent
Bernafon, Inc.
1125 Globe Ave.
P.O. Box 1160
Mountainside,  NJ  07092
Correspondent Contact TED MIKSIEWICZ
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/16/1985
Decision Date 05/29/1985
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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