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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 K031053
Device Name SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7
Applicant
Selectivemed Components, Inc.
201 W. High St.
Mount Vernon,  OH  43050
Applicant Contact RICHARD J FISHER
Correspondent
Selectivemed Components, Inc.
201 W. High St.
Mount Vernon,  OH  43050
Correspondent Contact RICHARD J FISHER
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received04/02/2003
Decision Date 05/20/2003
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
Recalls CDRH Recalls
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