FDA 510(k) Application Details - K210621

Device Classification Name	More FDA Info for this Device
510(K) Number	K210621
Device Name	Oral/Enteral Syringe
Applicant	Ningbo Tianyi Medical Appliance Co., Ltd. No.788, Mozhi North Road, Tourism Resort, Dongqian Lake Ningbo 315121 CN Other 510(k) Applications for this Company
Contact	Wenyu 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	03/02/2021
Decision Date	04/28/2021
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