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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 K203513
Device Name SLENDERTONE Evolve Abs, Type 735
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 Received11/30/2020
Decision Date 02/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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