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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K081585
Device Name ENDOSCOPY VIDEO CAMERA SYSTEM
Applicant
Vision Systems Group, A Division of Viking Systems
10 Greenlawn Ave.
South Grafton,  MA  01560
Applicant Contact CHRISTINE E NICHOLS
Correspondent
Vision Systems Group, A Division of Viking Systems
10 Greenlawn Ave.
South Grafton,  MA  01560
Correspondent Contact CHRISTINE E NICHOLS
Regulation Number876.1500
Classification Product Code
FET  
Date Received06/05/2008
Decision Date 06/20/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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