FDA 510(k) Application Details - K071573

Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes

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510(K) Number K071573
Device Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant FATROTEK S.R.L.
ROUTE DE LA GARE, 36
AUVERNIER 2012 CH
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Contact FRANSICO PELUSO
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Regulation Number 882.5890

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Classification Product Code NFO
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Date Received 06/08/2007
Decision Date 12/09/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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