FDA 510(k) Application Details - K191490

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K191490
Device Name	Syringe, Antistick
Applicant	Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town Jiangyin 214425 CN Other 510(k) Applications for this Company
Contact	Xinyan Ruan 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	06/05/2019
Decision Date	10/03/2019
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