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FDA 510(k) Application Details - K183406
Device Classification Name
Device, Monitoring, Intracranial Pressure
More FDA Info for this Device
510(K) Number
K183406
Device Name
Device, Monitoring, Intracranial Pressure
Applicant
Integra LifeSciences Corp.
11 Cabot Blvd
Mansfield, MA 02048 US
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Contact
Megan Palumbo
Other 510(k) Applications for this Contact
Regulation Number
882.1620
More FDA Info for this Regulation Number
Classification Product Code
GWM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/10/2018
Decision Date
01/11/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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