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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 K945032
Device Name VOYAGER 522
Applicant
MADSEN ELECTRONICS, INC.
5600 ROWLAND RD.
MINNETONKA,  MN  55343
Applicant Contact LOIS DONNAY
Correspondent
MADSEN ELECTRONICS, INC.
5600 ROWLAND RD.
MINNETONKA,  MN  55343
Correspondent Contact LOIS DONNAY
Regulation Number874.1050
Classification Product Code
EWO  
Date Received10/13/1994
Decision Date 02/02/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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