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510(k) K080580

COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D by Axelgaard Mfg. Co., Ltd. — Product Code EGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2008
Date Received
March 3, 2008
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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  • K970426 — VALUETRODE (May 9, 1997)
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