510(k) K061522

TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM by Activatek, Inc. — Product Code EGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2006
Date Received
June 2, 2006
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