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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 K031769
Device Name E-STRIP
Applicant
Eemso, Inc.
1900 K St. NW
Washington,  DC  20006
Applicant Contact LARRY R PILOT
Correspondent
Eemso, Inc.
1900 K St. NW
Washington,  DC  20006
Correspondent Contact LARRY R PILOT
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received06/09/2003
Decision Date 10/14/2003
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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
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