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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 K850763
Device Name EARETTE HEARING AID OTICON E32U
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 Received02/25/1985
Decision Date 03/25/1985
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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