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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 K874218
Device Name HEARING AID (ALL-IN-THE-EAR)
Applicant
Audiology & Hearing Aid Clinic
165 Charles St.
Rochester,  NH  03867
Applicant Contact O'DAY, M.A.
Correspondent
Audiology & Hearing Aid Clinic
165 Charles St.
Rochester,  NH  03867
Correspondent Contact O'DAY, M.A.
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/16/1987
Decision Date 12/11/1987
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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