FDA 510(k) Application Details - K161811

Device Classification Name	More FDA Info for this Device
510(K) Number	K161811
Device Name	Medela Low Dose Enteral Syringe
Applicant	Medela, Inc. 785 Challenger Street Brea, CA 92821 US Other 510(k) Applications for this Company
Contact	Fergie Ferguson 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	07/01/2016
Decision Date	02/15/2017
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