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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 K860759
Device Name CHARISMA HEARING AID
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 Received02/28/1986
Decision Date 04/11/1986
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
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