FDA 510(k) Application Details - K150826

Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes

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510(K) Number K150826
Device Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant NUTRA LUXE MD, LLC
6835 INTERNATIONAL CENTER BLVD UNIT 4-5
FORT MYERS, FL 33912 US
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Contact PETER VON BERG
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Regulation Number 882.5890

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Classification Product Code NFO
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Date Received 03/30/2015
Decision Date 02/10/2016
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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