FDA 510(k) Application Details - K132905

Device Classification Name	Set, Blood Transfusion   More FDA Info for this Device
510(K) Number	K132905
Device Name	Set, Blood Transfusion
Applicant	ARTERIOCYTE MEDICAL SYSTEMS, INC. 45 SOUTH STREET HOPKINTON, MA 01748 US Other 510(k) Applications for this Company
Contact	ANN CHAREST Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	BRZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/16/2013
Decision Date	10/04/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review