Device Classification Name	Set, Administration, Intravascular
510(k) Number	K984569
Device Name	AB2 MED-FLO SOLUTION SET
Applicant	AB2 MEDICAL PRODUCTS, LLP 52 BUTTONBUSH CT. THE WOODLANDS,  TX  77380 -0926
Applicant Contact	ARTHUR CHANDLER,III
Correspondent	AB2 MEDICAL PRODUCTS, LLP 52 BUTTONBUSH CT. THE WOODLANDS,  TX  77380 -0926
Correspondent Contact	ARTHUR CHANDLER,III
Regulation Number	880.5440
Classification Product Code	FPA
Date Received	12/23/1998
Decision Date	08/12/1999
Decision	Substantially Equivalent (SESE)
Regulation Medical Specialty	General Hospital
510k Review Panel	General Hospital
Statement	Statement
Type	Traditional
Reviewed by Third Party	No
Combination Product	No