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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 K953603
Device Name HEARING TODAY HEARING AID
Applicant
Hearing Today Laboratory, Inc.
11954 W. 95th St.
Lenexa,  KS  66215
Applicant Contact JAMES V CAIN
Correspondent
Hearing Today Laboratory, Inc.
11954 W. 95th St.
Lenexa,  KS  66215
Correspondent Contact JAMES V CAIN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/02/1995
Decision Date 11/13/1995
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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