FDA 510(k) Application Details - K161471

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K161471
Device Name	Injector And Syringe, Angiographic
Applicant	Coeur, Inc. 100 Physicians Way Lebanon, TN 37090 US Other 510(k) Applications for this Company
Contact	Priscilla Clinner Other 510(k) Applications for this Contact
Regulation Number	870.1650   More FDA Info for this Regulation Number
Classification Product Code	DXT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/27/2016
Decision Date	10/06/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review