FDA 510(k) Application Details - K010647

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K010647
Device Name	Set, Administration, Intravascular
Applicant	STERLING MEDIVATIONS, INC. 180 FERNDALE RD. SOUTH WAYZATA, MN 55391 US Other 510(k) Applications for this Company
Contact	JOEL DOUGLAS 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	03/05/2001
Decision Date	04/13/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review