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FDA 510(k) Application Details - K020780
Device Classification Name
Device, Monitoring, Intracranial Pressure
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510(K) Number
K020780
Device Name
Device, Monitoring, Intracranial Pressure
Applicant
MEDEX, INC.
6250 SHIER RINGS RD.
DUBLIN, OH 43016 US
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BARBARA LAW
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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
03/11/2002
Decision Date
05/20/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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