FDA 510(k) Application Details - K062616

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

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510(K) Number K062616
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant INTELSOURCE GROUP, INC.
1676 VILLAGE GREEN
SUITE A
CROFTON, MD 21114 US
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Contact E.J. Smith
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 09/05/2006
Decision Date 07/06/2007
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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