510(k) K931550

EZ ADMINISTRATION SET by Y — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1994
Date Received
March 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type