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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K193250
Device Name Irrigation Tubing with CO2 or Air
Applicant
Keymed (Medical and Industrial Equipment) , Ltd.
Keymed House, Stock Rd.
Southend-On-Sea,  GB SS2 5QH
Applicant Contact Andy Hollingsworth
Correspondent
Olympus Surgical Tech America - Gyrus Acmi, Inc.
136 Tpke. Rd.
Southborough,  MA  01772
Correspondent Contact Mary Anne Patella
Regulation Number876.1500
Classification Product Code
OCX  
Date Received11/25/2019
Decision Date 04/06/2020
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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