FDA 510(k) Application Details - K181374

Device Classification Name	More FDA Info for this Device
510(K) Number	K181374
Device Name	NRFit Syringe
Applicant	Jiangsu Caina Medical Co., Ltd No. 23, Huanxi Road, Zhutang Town Jiangyin 214421 CN Other 510(k) Applications for this Company
Contact	Jun Lu Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2018
Decision Date	12/14/2018
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