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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 K873189
Device Name HEARING AID (ALL-IN-THE-EAR)
Applicant
SIGHT-N-SOUND & CO.
220 S. LYON STREET, SUITE E
HEMET,  CA  92343
Applicant Contact DAVID N WRIGHT
Correspondent
SIGHT-N-SOUND & CO.
220 S. LYON STREET, SUITE E
HEMET,  CA  92343
Correspondent Contact DAVID N WRIGHT
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/13/1987
Decision Date 09/16/1987
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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