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FDA 510(k) Application Details - K173192
Device Classification Name
Device, Monitoring, Intracranial Pressure
More FDA Info for this Device
510(K) Number
K173192
Device Name
Device, Monitoring, Intracranial Pressure
Applicant
Codman & Shurtleff, Inc
325 Paramount Drive
Raynham, MA 02767 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
10/02/2017
Decision Date
11/08/2017
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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