FDA 510(k) Application Details - K210444

Device Classification Name	More FDA Info for this Device
510(K) Number	K210444
Device Name	EZ-Injec LDV Sterile Safety Needle
Applicant	Poonglim Pharmatech Inc. 21, Jayumuyeok 1-gil Gunsan KR Other 510(k) Applications for this Company
Contact	Cho Hee Min Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/2021
Decision Date	02/16/2021
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