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FDA 510(k) Application Details - K161010
Device Classification Name
Device, Monitoring, Intracranial Pressure
More FDA Info for this Device
510(K) Number
K161010
Device Name
Device, Monitoring, Intracranial Pressure
Applicant
InnerSpace Neuro Solutions, Inc.
1622 Edinger Ave Suite C
Tustin, CA 92780 US
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Contact
Gary G. Frugard
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
04/11/2016
Decision Date
10/20/2016
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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