FDA 510(k) Application Details - K221860

Device Classification Name	More FDA Info for this Device
510(K) Number	K221860
Device Name	PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
Applicant	Poonglim Pharmatech Inc. 21, Jayumuyeok 1-Gil Gunsan 54001 KR Other 510(k) Applications for this Company
Contact	Hee Min Cho 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	06/27/2022
Decision Date	09/15/2023
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