FDA 510(k) Application Details - K212525

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K212525
Device Name	Set, I.V. Fluid Transfer
Applicant	Advcare Medical No. 36, Sinsing Street, Shulin District New Taipei 23877 TW Other 510(k) Applications for this Company
Contact	Meng T. Tan Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	LHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/2021
Decision Date	08/19/2022
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