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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
510(k) Number K874651
Device Name OTICON HEARING AID MODEL I52
Applicant
OTICON CORP.
29 SCHOOLHOUSE RD.
P.O. BOX 6724
somerset,  NJ  08873
Applicant Contact preben brunved
Correspondent
OTICON CORP.
29 SCHOOLHOUSE RD.
P.O. BOX 6724
somerset,  NJ  08873
Correspondent Contact preben brunved
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/13/1987
Decision Date 01/19/1988
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
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