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FDA 510(k) Application Details - K153658
Device Classification Name
Device, Neurovascular Embolization
More FDA Info for this Device
510(K) Number
K153658
Device Name
Device, Neurovascular Embolization
Applicant
Stryker Neurovascular
47900 Bayside Parkway
Fremont, CA 94538-2588 US
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Contact
Kate Taylor
Other 510(k) Applications for this Contact
Regulation Number
882.5950
More FDA Info for this Regulation Number
Classification Product Code
HCG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/21/2015
Decision Date
05/19/2016
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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