FDA 510(k) Application Details - K192679

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K192679
Device Name	Syringe, Antistick
Applicant	Gemtier Medical (Shanghai) Inc. No.18 Jianding Road, Fengjing Town, Jinshan District Shanghai 201502 CN Other 510(k) Applications for this Company
Contact	Lenny Cao 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	09/26/2019
Decision Date	04/10/2020
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