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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 K880349
Device Name MODEL 759 CUSTOM IN-THE-EAR HEARING AID
Applicant
Bernafon, Inc.
1125 Globe Ave.
P.O. Box 1160
Mountainside,  NJ  07092
Applicant Contact GEORGE W BALL
Correspondent
Bernafon, Inc.
1125 Globe Ave.
P.O. Box 1160
Mountainside,  NJ  07092
Correspondent Contact GEORGE W BALL
Regulation Number874.3300
Classification Product Code
ESD  
Date Received01/26/1988
Decision Date 03/07/1988
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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