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FDA 510(k) Application Details - K003905
Device Classification Name
Device, Monitoring, Intracranial Pressure
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510(K) Number
K003905
Device Name
Device, Monitoring, Intracranial Pressure
Applicant
INNERSPACE, INC.
2933 SOUTH PULLMAN ST.,
SUITE A
SANTA ANA, CA 92705 US
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Contact
DONALD E BOBO
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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
12/19/2000
Decision Date
06/15/2001
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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