FDA 510(k) Application Details - K971701

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K971701
Device Name	Set, Administration, Intravascular
Applicant	BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. ROUND LAKE, IL 60073 US Other 510(k) Applications for this Company
Contact	MARY ELLEN SNYDER 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	05/08/1997
Decision Date	06/06/1997
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