FDA 510(k) Application Details - K173093

Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes

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510(K) Number K173093
Device Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant TAMA Research Corporation
7600 North 16th Street,
Suite 205
Phoenix, AZ 85020 US
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Contact Ali Shambayati
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Regulation Number 882.5890

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Classification Product Code NFO
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Date Received 09/29/2017
Decision Date 06/05/2018
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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