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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K182819
FOIA Releasable 510(k) K182819
Device Name Decanting Device
Applicant
Gcmedica Enterprise Ltd.(Wuxi)
Loujin Industrial Park, Shuofang
Wuxi,  CN 214143
Applicant Contact Mona Zhang
Correspondent
Shanghai Thinkwell Consulting Co., Ltd.
Xinling Rd., 211/6f
Shanghai,  CN 201100
Correspondent Contact Ethan Liu
Regulation Number880.5440
Classification Product Code
LHI  
Date Received10/04/2018
Decision Date 12/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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