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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K003913
Device Name HINT AUDIOMETER, OR HINT
Applicant
Maico-Diagnostics
9675 W. 76th St.
Eden Prairie,  MN  55344
Applicant Contact DANIEL EGGAN
Correspondent
Maico-Diagnostics
9675 W. 76th St.
Eden Prairie,  MN  55344
Correspondent Contact DANIEL EGGAN
Regulation Number874.1050
Classification Product Code
EWO  
Date Received12/19/2000
Decision Date 03/16/2001
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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