FDA 510(k) Application Details - K063114

Device Classification Name	Tubing, Fluid Delivery   More FDA Info for this Device
510(K) Number	K063114
Device Name	Tubing, Fluid Delivery
Applicant	COEUR, INC. 704 CADET COURT LEBANON, TN 37087 US Other 510(k) Applications for this Company
Contact	DEBRA F MANNING Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/11/2006
Decision Date	02/09/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review