510(k) K933898

HUBER NEEDLE SETS by Mediziv Medical Products 1987 , Ltd. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1995
Date Received
August 10, 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