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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 K780699
Device Name EARETTE HEARING AID
Applicant
OPTICON CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
OPTICON CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/26/1978
Decision Date 05/03/1978
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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