510(k) K103103

PRESSON ELECTRODE by Persyst Development Corp. — Product Code GXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2011
Date Received
October 20, 2010
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