510(k) K103562

CENTURION PRESSURE INJECTABLE EXTENSION SET by Centurion Medical Products Corporation — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2011
Date Received
December 6, 2010
Clearance Type
Abbreviated
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