FDA 510(k) Application Details - K083121

Device Classification Name	Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position   More FDA Info for this Device
510(K) Number	K083121
Device Name	Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
Applicant	CORPAK MEDSYSTEMS 100 CHADDICK DR. WHEELING, IL 60090 US Other 510(k) Applications for this Company
Contact	STEPHANIE WASIELEWSKI Other 510(k) Applications for this Contact
Regulation Number	880.5970   More FDA Info for this Regulation Number
Classification Product Code	OMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/22/2008
Decision Date	02/11/2009
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	N
Expedited Review