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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K250432
Device Name Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)
Applicant
Olympus Medical Systems Corporation
2951 Ishikawa-Cho
Hachioji-Shi,  JP 192-8507
Applicant Contact Shinichiro Kawachi
Correspondent
Olympus Corporation of the Americas
800 W. Park Dr.
Westborough,  MA  01581
Correspondent Contact Teffany Hutto
Regulation Number876.1500
Classification Product Code
FDF  
Subsequent Product Codes
FDS   NWB  
Date Received02/14/2025
Decision Date 05/15/2025
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
Predetermined Change
Control Plan Authorized		 No
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