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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
# 28-2, Shun Jeau Diann, Chunan Town
Miaoli County,  CN 35056
Applicant Contact Steven Shen
Correspondent
Benq Medical Technology Corporation
3f, # 159, Shan-Ying Rd., 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
Predetermined Change
Control Plan Authorized		 No
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