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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 K873001
Device Name HEARING AID (ALL-IN-THE-EAR)
Applicant
LITTLEFIELD CO.
57 EAST BROADWAY
SALT LAKE CITY,  UT  84111
Applicant Contact MICHAEL LITTLEFIELD
Correspondent
LITTLEFIELD CO.
57 EAST BROADWAY
SALT LAKE CITY,  UT  84111
Correspondent Contact MICHAEL LITTLEFIELD
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/04/1987
Decision Date 09/04/1987
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
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