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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, transcutaneous electrical, aesthetic purposes
510(k) Number K192077
Device Name Tua Face Fitness / Tua Trend Face
Applicant
Vupiesse S.R.L
Via della Lontra, 49
Rimini RN,  IT 47923
Applicant Contact Marco Paolizzi
Correspondent
Silicus Technologies
2700 Post Oak Blvd #1625
Houston,  TX  77056
Correspondent Contact Chuck H. Mograbi
Regulation Number882.5890
Classification Product Code
NFO  
Date Received08/02/2019
Decision Date 09/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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