FDA 510(k) Application Details - K211593

Device Classification Name	More FDA Info for this Device
510(K) Number	K211593
Device Name	Enteral Pump Syringe
Applicant	Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town Jiangyin 214415 CN Other 510(k) Applications for this Company
Contact	Jianwei Pan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2021
Decision Date	09/30/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review