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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 K202646
Device Name Visera Elite II Video System Center
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi,  JP 192-8507
Applicant Contact Toshiyuki Nakajima
Olympus Surgical Technologies of America
118 Turnpike Road, Suite 120
Southborough,  MA  01772
Correspondent Contact Anne-Marie Keefe
Regulation Number876.1500
Classification Product Code
Subsequent Product Code
Date Received09/11/2020
Decision Date 10/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No