FDA 510(k) Application Details - K192179

Device Classification Name	More FDA Info for this Device
510(K) Number	K192179
Device Name	Oral/Enteral Syringe
Applicant	Shanghai Kindly Enterprise Development Group Co., Ltd No. 658 Gaochao Road Shanghai 201803 CN Other 510(k) Applications for this Company
Contact	Weixin Zhang 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	08/12/2019
Decision Date	05/01/2020
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