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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 K222780
Device Name LILY Extension Tube and Needleless Connector
Applicant
LILY Medical Corporation
No. 28-2, Shun Jeau Diann, Chunan Town
Miaoli County,  CN 35056
Applicant Contact Steven Shen
Correspondent
BenQ Medical Technology Corporation
3F, No. 159, Shan-Ying Road, Shan-Ding Village
Gueishan Dist.
Taoyuan,  CN 333
Correspondent Contact Steven Shen
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/14/2022
Decision Date 11/09/2023
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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