510(k) K020424

V SET by Hennig Enterprises Europe Srl — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2003
Date Received
February 8, 2002
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