FDA 510(k) Application Details - K090866

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

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510(K) Number K090866
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant NEUROMED DEVICES, INC
29461 TROON ST
LAGUNA NIGEL, CA 92677 US
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Contact ROBERT SEIPLE
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 03/31/2009
Decision Date 10/21/2009
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 Y
Expedited Review



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