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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 K063452
Device Name MA 55 MAESTRO
Applicant
Maico Diagnostics (Diagnostic Group, LLC)
7625 Golden Triangle D
Eden Prairie,  MN  55344
Applicant Contact DANIEL EGGAN
Correspondent
Maico Diagnostics (Diagnostic Group, LLC)
7625 Golden Triangle D
Eden Prairie,  MN  55344
Correspondent Contact DANIEL EGGAN
Regulation Number874.1050
Classification Product Code
EWO  
Date Received11/15/2006
Decision Date 03/29/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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