510(k) K032968

TRSANSDERM IONTO SYSTEM by Mattioli Engineering Corp. — Product Code EGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2003
Date Received
September 23, 2003
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