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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
510(k) Number K232334
Device Name DEKA SIMON
Applicant
El.En S.P.A.
Via Baldanzese 17
Calenzano,  IT 50141
Applicant Contact Paolo Peruzzi
Correspondent
El.En S.P.A.
Via Baldanzese 17
Calenzano,  IT 50141
Correspondent Contact Paolo Peruzzi
Regulation Number890.5850
Classification Product Code
IPF  
Date Received08/04/2023
Decision Date 09/01/2023
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
Predetermined Change
Control Plan Authorized		 No
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