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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 K151903
Device Name Slendertone connect Abs
Applicant
Bio-Medical Research, Ltd.
Parkmore Business Park W.
Galway H91 Vy19,  IE
Applicant Contact ANNE-MARIE KEENAN
Correspondent
Bio-Medical Research, Ltd.
Parkmore Business Park W.
Galway H91 Vy19,  IE
Correspondent Contact ANNE-MARIE KEENAN
Regulation Number890.5850
Classification Product Code
NGX  
Date Received07/10/2015
Decision Date 11/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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