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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 K894428
Device Name HEARING AID (IN-THE-EAR)
Applicant
Hearing Aid Express
2877 Lbj Fwy., Suite 160
Dallas,  TX  75234
Applicant Contact MCGINNAS, JR.
Correspondent
Hearing Aid Express
2877 Lbj Fwy., Suite 160
Dallas,  TX  75234
Correspondent Contact MCGINNAS, JR.
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/17/1989
Decision Date 10/24/1989
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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