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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 K853919
Device Name MA25 PORTABLE AUDIOMETER
Applicant
MAICO HEARING INSTRUMENTS, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439 -2029
Applicant Contact PAUL M D'AMICO
Correspondent
MAICO HEARING INSTRUMENTS, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439 -2029
Correspondent Contact PAUL M D'AMICO
Regulation Number874.1050
Classification Product Code
EWO  
Date Received09/23/1985
Decision Date 12/18/1985
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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