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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 K873338
Device Name HORN CUSTOM AID
Applicant
HEARING AIDS BY GUY HORN
6407 BRENTWOOD STAIR RD.
FORT WORTH,  TX  76112
Applicant Contact GUY HORN
Correspondent
HEARING AIDS BY GUY HORN
6407 BRENTWOOD STAIR RD.
FORT WORTH,  TX  76112
Correspondent Contact GUY HORN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/19/1987
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
Predetermined Change
Control Plan Authorized		 No
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