FDA 510(k) Application Details - K122711

Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes

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510(K) Number K122711
Device Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant NUSKIN
ONE METRO CENTER 700
12TH STREET, SUITE 900
WASHINGTON, DC 20005 US
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Contact PAUL RUBIN
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Regulation Number 882.5890

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Classification Product Code NFO
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Date Received 09/04/2012
Decision Date 09/17/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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