FDA 510(k) Application Details - DEN070014

Device Classification Name

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510(K) Number DEN070014
Device Name MANDOMETER III
Applicant AB MANDO
16787 BERNARDO CENTER DRIVE
SUITE A-1
SAN DIEGO, CA 92128 US
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Contact KIM BLOOM
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Regulation Number

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Classification Product Code OBV
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Date Received 06/20/2007
Decision Date 03/31/2011
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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