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FDA 510(k) Application Details - K222780
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K222780
Device Name
Set, Administration, Intravascular
Applicant
LILY Medical Corporation
No. 28-2, Shun Jeau Diann, Chunan Town
Miaoli County 35056 CN
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Contact
Steven Shen
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/14/2022
Decision Date
11/09/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K222780
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