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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K181870
Device Name Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use
Applicant
Wuhan W.E.O Science & Technology Development Co., Ltd.
No.18, Huanhu Mid. Rd., Jinyin Lake, Dongxihu Dist
Wuhun,  CN 430040
Applicant Contact Chengling Fu
Correspondent
Mid-Link Consulting Co., Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
FPB  
Date Received07/12/2018
Decision Date 02/26/2019
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
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