FDA 510(k) Application Details - K232987

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K232987
Device Name	Set, I.V. Fluid Transfer
Applicant	Asset Medikal Tasarim Sanayi Ve Ticaret A.S. Ikitelli OSB Mah., 17. Cd, No:17 Basaksehir Istanbul 34303 TR Other 510(k) Applications for this Company
Contact	Ebru Sirali 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	09/22/2023
Decision Date	06/26/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review