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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 K092244
Device Name MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS
Applicant
Diagnostic Group, LLC
7625 Golden Triangle Dr.
Minnesota,  MN  55344
Applicant Contact DANIEL EGGAN
Correspondent
Diagnostic Group, LLC
7625 Golden Triangle Dr.
Minnesota,  MN  55344
Correspondent Contact DANIEL EGGAN
Regulation Number874.1050
Classification Product Code
EWO  
Date Received07/28/2009
Decision Date 03/01/2010
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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