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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 K982441
Device Name CCA-220
Applicant
Benson Medical Instruments Co.
2344 Nicollet Ave. S., #150
Minneapolis,  MN  55404
Applicant Contact DAVID P MAYOU
Correspondent
Benson Medical Instruments Co.
2344 Nicollet Ave. S., #150
Minneapolis,  MN  55404
Correspondent Contact DAVID P MAYOU
Regulation Number874.1050
Classification Product Code
EWO  
Date Received07/14/1998
Decision Date 10/09/1998
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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