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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 K963681
Device Name CCA-100 (MODIFIED)
Applicant
BENSON MEDICAL INSTRUMENTS CO.
2344 NICOLLET AVE. SOUTH, #150
MINNEAPOLIS,  MN  55404
Applicant Contact DAVID P MAYOU
Correspondent
BENSON MEDICAL INSTRUMENTS CO.
2344 NICOLLET AVE. SOUTH, #150
MINNEAPOLIS,  MN  55404
Correspondent Contact DAVID P MAYOU
Regulation Number874.1050
Classification Product Code
EWO  
Date Received07/11/1996
Decision Date 10/08/1996
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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