510(k) K031551

NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) by Vyteris, Inc. — Product Code KTB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2003
Date Received
May 19, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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