510(k) K002471

JETCAN HUBER NEEEDLE SET by Pfm Produkte Fur Die Medizin AG — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2000
Date Received
August 11, 2000
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