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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 K240352
Device Name Defendo Single Use Cleaning Adapter for Olympus Endoscopes
Applicant
STERIS Corporation
5976 Heisley Road
Mentor,  OH  44060
Applicant Contact Carroll Martin
Correspondent
STERIS Corporation
5976 Heisley Road
Mentor,  OH  44060
Correspondent Contact Carroll Martin
Regulation Number876.1500
Classification Product Code
ODC  
Date Received02/05/2024
Decision Date 03/06/2024
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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