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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, Other Uses
510(k) Number K080580
Device Name COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D
Applicant
Axelgaard Mfg. Co., Ltd.
520 Industrial Way
Fallbrook,  CA  92028 -2244
Applicant Contact DAN P JEFFERY
Correspondent
Axelgaard Mfg. Co., Ltd.
520 Industrial Way
Fallbrook,  CA  92028 -2244
Correspondent Contact DAN P JEFFERY
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received03/03/2008
Decision Date 06/18/2008
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 No
Predetermined Change
Control Plan Authorized		 No
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