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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 K853635
Device Name SUBDERM TM
Applicant
General Medical Co.
1575 Eye St. NW
Washington,  DC  20005
Applicant Contact LARRY R PILOT
Correspondent
General Medical Co.
1575 Eye St. NW
Washington,  DC  20005
Correspondent Contact LARRY R PILOT
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received08/30/1985
Decision Date 12/20/1985
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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