FDA 510(k) Application Details - K222780

Device Classification Name Set, Administration, Intravascular

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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
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Regulation Number 880.5440

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Classification Product Code FPA
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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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