FDA 510(k) Application Details - K013394

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K013394
Device Name	Set, Administration, Intravascular
Applicant	SPECIALIZED HEALTH PRODUCTS, INC. 585 WEST 500 SOUTH 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	10/15/2001
Decision Date	11/08/2001
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