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FDA 510(k) Application Details - K181301
Device Classification Name
Shunt, Central Nervous System And Components
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510(K) Number
K181301
Device Name
Shunt, Central Nervous System And Components
Applicant
Aqueduct Critical Care, Inc.
11822 North Creek Parkway North
Suite 110
Bothell, WA 98011 US
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Contact
Thomas Clement
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Regulation Number
882.5550
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Classification Product Code
JXG
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Date Received
05/17/2018
Decision Date
06/14/2018
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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