510(k) K073229

NERVE MONITORING CABLE by Pioneer Surgical Technology — Product Code GXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2008
Date Received
November 15, 2007
Clearance Type
Abbreviated
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