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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, air, non-manual, for endoscope
510(k) Number K220395
Device Name EndoGator Endoscopy Irrigation Tubing
Applicant
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Applicant Contact Carroll Martin
Correspondent
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Correspondent Contact Carroll Martin
Regulation Number876.1500
Classification Product Code
FEQ  
Date Received02/11/2022
Decision Date 03/11/2022
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
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