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FDA 510(k) Application Details - K092625
Device Classification Name
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510(K) Number
K092625
Device Name
WAVESTATE NEUROMONITOR
Applicant
WAVESTATE INC
1468 HARWELL AVE
CROFTON, MD 21114 US
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Contact
E.J. Smith
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Regulation Number
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Classification Product Code
ORT
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Date Received
08/27/2009
Decision Date
06/29/2010
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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