FDA 510(k) Application Details - K193657

Device Classification Name	More FDA Info for this Device
510(K) Number	K193657
Device Name	Disposable Enteral Feeding Syringe with Enfit Connector
Applicant	Shinva Ande Healthcare Apparatus Co., Ltd. No.77 Development Zone North Road Zibo 255086 CN Other 510(k) Applications for this Company
Contact	Xiaolei Tian 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	12/30/2019
Decision Date	09/12/2020
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