FDA 510(k) Application Details - K213013

Device Classification Name	More FDA Info for this Device
510(K) Number	K213013
Device Name	Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
Applicant	Jeil Tech Co., Ltd. 190, Maesilro, Sojeongmyeon Sejong-si 54001 KR Other 510(k) Applications for this Company
Contact	Chun-Gi Lee 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	09/20/2021
Decision Date	09/19/2022
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