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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 K071573
Device Name RUGALIFT, MODEL# V.2.1
Applicant
FATROTEK S.R.L.
ROUTE DE LA GARE, 36
AUVERNIER,  CH 2012
Applicant Contact FRANSICO PELUSO
Correspondent
FATROTEK S.R.L.
ROUTE DE LA GARE, 36
AUVERNIER,  CH 2012
Correspondent Contact FRANSICO PELUSO
Regulation Number882.5890
Classification Product Code
NFO  
Date Received06/08/2007
Decision Date 12/09/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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