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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 K161582
FOIA Releasable 510(k) K161582
Device Name DORA Tubing Sets for Hemodialysis
Applicant
Bain Medical Equipment (Guangzhou) Co., Ltd.
# 10 Juncheng Rd.
Eastern Zone Of Guangzhou Economic & Technological
Guangzhou,  CN 510760
Applicant Contact Sophia Shao
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number876.5820
Classification Product Code
FJK  
Date Received06/08/2016
Decision Date 06/16/2017
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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