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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 K202104
Device Name BioGuard EUS Air/Water and Suction Valves
Applicant
STERIS Corporation
5976 Heisley Rd.
Mentor,  OH  44060
Applicant Contact Carroll Martin
Correspondent
STERIS Corporation
5976 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact Carroll Martin
Regulation Number876.1500
Classification Product Code
ODC  
Subsequent Product Code
FDF  
Date Received07/29/2020
Decision Date 01/14/2021
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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