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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 K180688
Device Name SLENDERTONE CoreFit Abs 8, Type 734
Applicant
Bio-Medical Research Ltd
Parkmore Business Park West
Galway,  IE H91 NHT7
Applicant Contact Eoin Keating
Correspondent
Bio-Medical Research Ltd
Parkmore Business Park West
Galway,  IE H91 NHT7
Correspondent Contact Eoin Keating
Regulation Number890.5850
Classification Product Code
NGX  
Date Received03/15/2018
Decision Date 10/25/2018
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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