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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 K901387
Device Name SEARS MODEL LI9097 IN-THE-EAR HEARING INSTRUMENT
Applicant
Miracle-Ear, Inc.
7731 Country Club Dr.
Golden Valley,  MN  55427
Applicant Contact KEVIN KUTINA
Correspondent
Miracle-Ear, Inc.
7731 Country Club Dr.
Golden Valley,  MN  55427
Correspondent Contact KEVIN KUTINA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/26/1990
Decision Date 04/16/1990
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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