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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 K233470
Device Name DEKA LILY
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
NGX  
Date Received10/25/2023
Decision Date 12/19/2023
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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