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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 K091317
Device Name LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK
Applicant
Bio-Medical Research, Ltd.
Bmr House
Parkmore Business Park, W.
Galway,  IE
Applicant Contact ANNE-MARIE KEENAN
Correspondent
Bio-Medical Research, Ltd.
Bmr House
Parkmore Business Park, W.
Galway,  IE
Correspondent Contact ANNE-MARIE KEENAN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/04/2009
Decision Date 06/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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