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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, tubing, blood, with and without anti-regurgitation valve
510(k) Number K150304
Device Name Oxyless Blood Tubing Set
Oxyless Ltd
Third Floor, Bewlay House, 2 Swallow Place
London,  GB
Applicant Contact Bob Duffy
Bob Duffy Associates
16405 Summer Sage Road
Poway,  CA  92064
Correspondent Contact Bob Duffy
Regulation Number876.5820
Classification Product Code
Date Received02/06/2015
Decision Date 02/24/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No