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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
510(k) Number K202583
Device Name BioShield biopsy valve EUS - Linear
Applicant
Steris Corporation
5976 Heisley Rd
Mentor,  OH  44060
Applicant Contact Jacqueline Oliver
Correspondent
Steris Corporation
5976 Heisley Rd
Mentor,  OH  44060
Correspondent Contact Jacqueline Oliver
Regulation Number876.1500
Classification Product Code
ODD  
Date Received09/08/2020
Decision Date 11/06/2020
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
Predetermined Change
Control Plan Authorized		 No
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