FDA 510(k) Application Details - K092990

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

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510(K) Number K092990
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant ADVANTAGEOUS MEDICAL DEVICES, LLC
1728 VIRGINIA BEACH BLVD
SUITE 115
VIRGINIA BEACH, VA 23454 US
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Contact JOHN HEROD
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 09/28/2009
Decision Date 10/23/2009
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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