FDA 510(k) Application Details - K070630

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K070630
Device Name	Set, Administration, Intravascular
Applicant	HEALTH LINE INTERNATIONAL CORPORATION (HLIC) PO BOX 160435 BLDG E-13 DOOR21 FREEPORT CENTER BLDG CLEARFIELD, UT 84016 US Other 510(k) Applications for this Company
Contact	DENICE WROE 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	03/07/2007
Decision Date	08/31/2007
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