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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Storage Cover
510(k) Number K191715
Device Name Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile
Applicant
STERIS Corporation
5976 Heisley Rd.
Mentor,  OH  44060
Applicant Contact Jennifer Nalepka
Correspondent
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact Jennifer Nalepka
Regulation Number876.1500
Classification Product Code
OCU  
Date Received06/26/2019
Decision Date 01/27/2020
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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