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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 K964680
Device Name COMFORTAID HEARING AID
Applicant
Ethical Hearing Instruments
90 Fleet St.
Portsmouth,  NH  03801
Applicant Contact DAVID J DELAGE
Correspondent
Ethical Hearing Instruments
90 Fleet St.
Portsmouth,  NH  03801
Correspondent Contact DAVID J DELAGE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/22/1996
Decision Date 01/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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