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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 K962388
Device Name IN THE EAR HEARING AID
Applicant
Unique Hearing Technology, Inc.
7000 57th Ave. N., #125
Crystal,  MN  55429
Applicant Contact LARRY LERITZ
Correspondent
Unique Hearing Technology, Inc.
7000 57th Ave. N., #125
Crystal,  MN  55429
Correspondent Contact LARRY LERITZ
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/20/1996
Decision Date 09/16/1996
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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