FDA 510(k) Application Details - K231363

Device Classification Name	Saline, Vascular Access Flush   More FDA Info for this Device
510(K) Number	K231363
Device Name	Saline, Vascular Access Flush
Applicant	Hantech Medical Device Co., Ltd. No 288 Sanheng Road, Changhe Industrial Park, Cixi Ningbo 315326 CN Other 510(k) Applications for this Company
Contact	Arnold Yang 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	05/11/2023
Decision Date	09/27/2023
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