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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 K043219
Device Name AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
Applicant
INTERACOUSTICS AS
7625 GOLDEN TRIANGLE DRIVE
EDEN PRAIRIE,  MN  55344
Applicant Contact DANIEL EGGAN
Correspondent
INTERACOUSTICS AS
7625 GOLDEN TRIANGLE DRIVE
EDEN PRAIRIE,  MN  55344
Correspondent Contact DANIEL EGGAN
Regulation Number874.1050
Classification Product Code
EWO  
Subsequent Product Code
ETW  
Date Received11/22/2004
Decision Date 02/04/2005
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
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