510(k) K983484

DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE by Empi — Product Code EGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1998
Date Received
October 5, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Iontophoresis, Other Uses
Device Class
Class II
Regulation Number
890.5525
Review Panel
PM
Submission Type