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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
Applicant
Oxyless Ltd
Third Floor, Bewlay House, 2 Swallow Place
London,  GB
Applicant Contact Bob Duffy
Correspondent
Bob Duffy Associates
16405 Summer Sage Road
Poway,  CA  92064
Correspondent Contact Bob Duffy
Regulation Number876.5820
Classification Product Code
FJK  
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
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