FDA 510(k) Application Details - K203410

Device Classification Name	More FDA Info for this Device
510(K) Number	K203410
Device Name	ENFit Disposable Enteral Syringe
Applicant	Shantou Wealy Medical Instrument Co., Ltd. North Jinhuan Road (near Qishan mid-school), Shantou China Shantou 515064 CN Other 510(k) Applications for this Company
Contact	Yang Songling 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	11/19/2020
Decision Date	06/28/2021
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