FDA 510(k) Application Details - K040633

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K040633
Device Name	Set, Administration, Intravascular
Applicant	UNOMEDICAL A/S AAHOLMVEJ 1-3, OSTED ROSKILDE DK-4000 DK Other 510(k) Applications for this Company
Contact	JOHN M LINDSKOG 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	03/10/2004
Decision Date	04/01/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review