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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 K895843
Device Name AHAC ITE MODEL ENTENDRE
Applicant
AROOSTOOK HEARING AID
P.O. BOX 939
341 WILSON STREET
BREWER,  ME  04412
Applicant Contact PAUL E DUBOIS
Correspondent
AROOSTOOK HEARING AID
P.O. BOX 939
341 WILSON STREET
BREWER,  ME  04412
Correspondent Contact PAUL E DUBOIS
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/03/1989
Decision Date 04/16/1990
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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