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510(k) K042590

TRANSDERM IONTO SYSTEM, MK 2 by Mattioli Engineering Corp. — Product Code EGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2004
Date Received
September 23, 2004
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

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