FDA 510(k) Application Details - K213010

Device Classification Name	More FDA Info for this Device
510(K) Number	K213010
Device Name	FEELject LDV (Low dead volume) syringe
Applicant	Feeltech Co., Ltd. 3, 4 Floor, Standard Factory 2-dong, 15, Jayumuyeok2-gil Gunsan 54001 KR Other 510(k) Applications for this Company
Contact	Kim Geun Sik 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	05/31/2023
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