FDA 510(k) Application Details - K990693

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K990693
Device Name	Set, Administration, Intravascular
Applicant	ACT MEDICAL, INC. 150 CALIFORNIA ST. NEWTON, MA 02458 US Other 510(k) Applications for this Company
Contact	WENDY V SHOTTS 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	03/03/1999
Decision Date	05/14/1999
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