FDA 510(k) Application Details - DEN110019

Device Classification Name

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510(K) Number DEN110019
Device Name NEBA SYSTEM
Applicant LEXICOR MEDICAL TECHNOLOGY, LLC
753 BROAD STREET
SUITE 701
AUGUSTA, GA 30901 US
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Contact E. HOWARD MERRY
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Regulation Number

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Classification Product Code NCG
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Date Received 12/08/2011
Decision Date 07/15/2013
Decision DENG -
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status
Type Post-NSE
Reviewed By Third Party N
Expedited Review



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