510(k) K050325

DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE by Technomed Europe — Product Code GXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2005
Date Received
February 9, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle
Device Class
Class II
Regulation Number
882.1350
Review Panel
NE
Submission Type