FDA 510(k) Application Details - K083454

Device Classification Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days   More FDA Info for this Device
510(K) Number	K083454
Device Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant	U.S. SAFETY SYRINGES CO., INC. 1676 VILLAGE GREEN CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	CHRISTINE SMITH Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	FOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2008
Decision Date	12/04/2008
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