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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrator, hearing aid / earphone and analysis systems
510(k) Number K113831
Device Name PRIMUS HEARING INSTRUMENT TEST UNIT
Original Applicant
AUDITDATA A/S
banestroeger 13
taastrup,  DK dk-2630
Original Contact dan haugbol
Regulation Number874.3310
Classification Product Code
ETW  
Subsequent Product Code
EWO  
Date Received12/27/2011
Decision Date 04/19/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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