FDA 510(k) Application Details - K050600

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K050600
Device Name	Set, Administration, Intravascular
Applicant	SPECIALIZED HEALTH PRODUCTS, INTL. 585 WEST 500 SOUTH SUITE 200 BOUNTIFUL, UT 84010 US Other 510(k) Applications for this Company
Contact	Mark Nelson 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	03/09/2005
Decision Date	05/12/2005
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	N
Expedited Review