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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 K896401
Device Name MICROMATE 304
Applicant
Madsen North America, Inc.
908 Niagara Falls Blvd.
North Tonawanda,  NY  14120
Applicant Contact ZOILA A SEERY
Correspondent
Madsen North America, Inc.
908 Niagara Falls Blvd.
North Tonawanda,  NY  14120
Correspondent Contact ZOILA A SEERY
Regulation Number874.1050
Classification Product Code
EWO  
Date Received11/07/1989
Decision Date 03/27/1990
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
Predetermined Change
Control Plan Authorized		 No
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