FDA 510(k) Application Details - K220060

Device Classification Name	Saline, Vascular Access Flush   More FDA Info for this Device
510(K) Number	K220060
Device Name	Saline, Vascular Access Flush
Applicant	Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Rd, Zhutang Town Jiangyin 214415 CN Other 510(k) Applications for this Company
Contact	Jianwei Pan Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	NGT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2022
Decision Date	06/10/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review