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FDA 510(k) Application Details - K161605
Device Classification Name
Shunt, Central Nervous System And Components
More FDA Info for this Device
510(K) Number
K161605
Device Name
Shunt, Central Nervous System And Components
Applicant
AQUEDUCT CRITICAL CARE, INC.
11822 NORTH CREEK PARKWAY NORTH
SUITE 110
Bothell, WA 98011 US
Other 510(k) Applications for this Company
Contact
Thomas Clement
Other 510(k) Applications for this Contact
Regulation Number
882.5550
More FDA Info for this Regulation Number
Classification Product Code
JXG
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More FDA Info for this Product Code
Date Received
06/10/2016
Decision Date
10/27/2016
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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