FDA 510(k) Application Details - K080665

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K080665
Device Name	Set, Administration, Intravascular
Applicant	U.S. SAFETY SYRINGES CO., INC. 1676 VILLAGE GREEN CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	CHRISTINA SMITH Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/10/2008
Decision Date	05/13/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review