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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 K844425
Device Name BEHIND THE EAR HEARING AIDS BERNAFON X-13
Applicant
Bernafon, Inc.
1125 Globe Ave.
P.O. Box 1160
Mountainside,  NJ  07092
Applicant Contact JAKOB SKADEGARD
Correspondent
Bernafon, Inc.
1125 Globe Ave.
P.O. Box 1160
Mountainside,  NJ  07092
Correspondent Contact JAKOB SKADEGARD
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/15/1984
Decision Date 01/04/1985
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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