FDA 510(k) Application Details - K131478

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K131478
Device Name	Injector And Syringe, Angiographic
Applicant	OSPREY MEDICAL, INC. 7600 EXECUTIVE DR EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	JILL MUNSINGER 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	05/22/2013
Decision Date	08/15/2013
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	Y
Expedited Review