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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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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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