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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K030140
Device Name DUOMED, SERIES 500, (MODELS ID 500, FL 500)
Applicant
Duomed, Inc.
400 Northpoint Pkwy. #406
West Palm Beach,  FL  33407
Applicant Contact CHARLES KOKINOS
Correspondent
Duomed, Inc.
400 Northpoint Pkwy. #406
West Palm Beach,  FL  33407
Correspondent Contact CHARLES KOKINOS
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received01/14/2003
Decision Date 03/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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