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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Channel Accessory
510(k) Number K241842
Device Name Luer-Split MAJ-2092
Applicant
Olympus Medical Systems Corporation
2951 Ishikawa-Cho
Hachioji-Shi,  JP 192-8507
Applicant Contact Shinichiro Kawachi
Correspondent
Olympus Surgical Technologies of America
800 W. Park Dr.
Westborough,  MA  01581
Correspondent Contact Rebecca Walker
Regulation Number876.1500
Classification Product Code
ODC  
Date Received06/26/2024
Decision Date 03/19/2025
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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