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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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