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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 K050496
Device Name REM440
Applicant
Interacoustics A/S, Assens
9675 W. 76th St.
Eden Prairie,  MN  55344
Applicant Contact DANIEL EGGAN
Correspondent
Interacoustics A/S, Assens
9675 W. 76th St.
Eden Prairie,  MN  55344
Correspondent Contact DANIEL EGGAN
Regulation Number874.3310
Classification Product Code
ETW  
Date Received02/28/2005
Decision Date 04/29/2005
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
Predetermined Change
Control Plan Authorized		 No
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