FDA 510(k) Application Details - K130919

Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief

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510(K) Number K130919
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant NEUROMETRIX, INC.
62 FOURTH AVE.
WALTHAM, MA 02451 US
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Contact RAINER MAAS
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 04/03/2013
Decision Date 07/02/2013
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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