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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning
510(k) Number K072294
Device Name SYSTEM-MINI, MODELS: 390, E30
Applicant
Bio-Medical Research, Ltd.
Parkmore Business Park W.
Galway,  IE
Applicant Contact ANNE-MARIE KEENAN
Correspondent
Bio-Medical Research, Ltd.
Parkmore Business Park W.
Galway,  IE
Correspondent Contact ANNE-MARIE KEENAN
Regulation Number890.5850
Classification Product Code
NGX  
Date Received08/16/2007
Decision Date 10/25/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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