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FDA 510(k) Application Details - K053244
Device Classification Name
Device, Monitoring, Intracranial Pressure
More FDA Info for this Device
510(K) Number
K053244
Device Name
Device, Monitoring, Intracranial Pressure
Applicant
INTEGRA LIFESCIENCES CORP.
311C ENTERPRISE DRIVE
PLAINSBORO, NJ 08536 US
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Contact
JON CAPAROTTA
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
11/21/2005
Decision Date
05/10/2006
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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