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FDA 510(k) Application Details - K131184
Device Classification Name
Device, Monitoring, Intracranial Pressure
More FDA Info for this Device
510(K) Number
K131184
Device Name
Device, Monitoring, Intracranial Pressure
Applicant
INTEGRA LIFESCIENCES CORP.
22 TERRY AVENUE
BURLINGTON, MA 01830 US
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Contact
ELIZABETH MCMENIMAN
Other 510(k) Applications for this Contact
Regulation Number
882.1620
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Classification Product Code
GWM
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More FDA Info for this Product Code
Date Received
04/25/2013
Decision Date
08/30/2013
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
N
Expedited Review
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