FDA 510(k) Application Details - K083250

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

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510(K) Number K083250
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant AA NEUROMED CORP.
1911 RODGER AVENUE
PORT COQUITLAM, BC V3C 1B8 CA
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Contact HERMANN DOLKER
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 11/04/2008
Decision Date 08/18/2009
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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