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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name duodenoscope and accessories, flexible/rigid
510(k) Number K193182
Device Name Evis Exera III Duodenovideoscope Olympus TJF-Q190V
Olympus Medical Systems Corp.
2951 Ishikawa-cho
hachioji-shi,  JP 192-8507
Applicant Contact toshiyuki nakajima
Olympus Corporation of the Americas
3500 Corporate Parkway PO Box 610
center valley,  PA  18034 -0610
Correspondent Contact sheri l. musgnung
Regulation Number876.1500
Classification Product Code
Subsequent Product Codes
Date Received11/18/2019
Decision Date 01/17/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls