FDA 510(k) Application Details - K212518

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K212518
Device Name	Syringe, Antistick
Applicant	JeeSung Medical Co., Ltd. 54, Mujini 1-gil, Daedeok-gu Daejeon 34340 KR Other 510(k) Applications for this Company
Contact	Choi Yong Hyun Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	MEG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/10/2021
Decision Date	08/18/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review