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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 K851430
Device Name EARETTE HEARING AID(BEHIND THE EAR OTICON E37F
Applicant
OTICON CORP.
P.O. BOX 424
29 SCHOOLHOUSE ROAD
SOMERSET,  NJ  08
Applicant Contact PREBEN BRUNVED
Correspondent
OTICON CORP.
P.O. BOX 424
29 SCHOOLHOUSE ROAD
SOMERSET,  NJ  08
Correspondent Contact PREBEN BRUNVED
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/10/1985
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
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