FDA 510(k) Application Details - K231856

Device Classification Name	More FDA Info for this Device
510(K) Number	K231856
Device Name	TopFine« LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
Applicant	MedExel Co., Ltd. 252, Geumgwangosan-ro, Geumgwang-myeon Anseong KR Other 510(k) Applications for this Company
Contact	Juntaek Seo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/2023
Decision Date	03/15/2024
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