FDA 510(k) Application Details - K163054

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K163054
Device Name	Injector And Syringe, Angiographic
Applicant	OSPREY MEDICAL, INC. 5600 ROWLAND ROAD SUITE 250 MINNETONKA, MN 55343 US Other 510(k) Applications for this Company
Contact	MELANIE HESS 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	11/01/2016
Decision Date	03/08/2017
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