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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 WEST
GALWAY,  IE
Applicant Contact ANNE-MARIE KEENAN
Correspondent
BIO-MEDICAL RESEARCH LTD.
PARKMORE BUSINESS PARK WEST
GALWAY,  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
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