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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Visual Reinforcement Audiometric
510(k) Number K897143
Device Name VERA 103
Applicant
Madsen North America, Inc.
908 Niagara Falls Blvd.
North Tonawanda,  NY  14120
Applicant Contact ZOILA SEERY
Correspondent
Madsen North America, Inc.
908 Niagara Falls Blvd.
North Tonawanda,  NY  14120
Correspondent Contact ZOILA SEERY
Regulation Number874.1050
Classification Product Code
LYN  
Date Received12/27/1989
Decision Date 04/27/1990
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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