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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 K023913
Device Name NEUROTECH BAXOLVE TYPE 294
Applicant
Bio-Medical Research, Ltd.
Parkmore Business Park
Galway,  IE
Applicant Contact MICHELLE SAWYER
Correspondent
Bio-Medical Research, Ltd.
Parkmore Business Park
Galway,  IE
Correspondent Contact MICHELLE SAWYER
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
IQE  
Date Received11/25/2002
Decision Date 08/25/2003
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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