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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 K030708
Device Name SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515
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 Number890.5850
Classification Product Code
NGX  
Date Received03/06/2003
Decision Date 06/25/2003
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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