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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Iontophoresis, Specific Uses
510(k) Number K031551
Device Name NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D)
Applicant
Vyteris, Inc.
13-01 Pollitt Dr.
Fair Lawn,  NJ  07410
Applicant Contact GEORGE M BASKINGER
Correspondent
Vyteris, Inc.
13-01 Pollitt Dr.
Fair Lawn,  NJ  07410
Correspondent Contact GEORGE M BASKINGER
Regulation Number890.5525
Classification Product Code
KTB  
Date Received05/19/2003
Decision Date 08/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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