510(k) K100090

IMPLANTABLE CLIP by Genicon — Product Code FZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2010
Date Received
January 12, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type