FDA 510(k) Application Details - K171857

Device Classification Name	More FDA Info for this Device
510(K) Number	K171857
Device Name	AMSure« Enteral Feeding Syringe with ENFit Tip
Applicant	Amsino International, Inc. 708 Corporate Center Drive Pomona, CA 91768 US Other 510(k) Applications for this Company
Contact	Cathy Hong 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	06/21/2017
Decision Date	03/30/2018
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