FDA 510(k) Application Details - K991112

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K991112
Device Name	Set, Administration, Intravascular
Applicant	SAGE LABORATORIES, INC. 5408 INTERSTATE DR. SHREVEPORT, LA 71109 US Other 510(k) Applications for this Company
Contact	DAVID CHEN 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	04/01/1999
Decision Date	09/02/1999
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