FDA 510(k) Application Details - K071846

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K071846
Device Name	Set, Administration, Intravascular
Applicant	PFM MEDICAL, INC 2605 TEMPLE HEIGHTS DRIVE SUITE A OCEANSIDE, CA 92056 US Other 510(k) Applications for this Company
Contact	SALVADORE PALOMARES 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	07/05/2007
Decision Date	08/30/2007
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