FDA 510(k) Application Details - K161045

Device Classification Name	More FDA Info for this Device
510(K) Number	K161045
Device Name	Monoject
Applicant	Covidien 15 Hampshire Street Mansfield, MA 02048 US Other 510(k) Applications for this Company
Contact	Sona Manickam 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	04/13/2016
Decision Date	06/17/2016
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