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FDA 510(k) Application Details - K180653
Device Classification Name
Device, Neurovascular Embolization
More FDA Info for this Device
510(K) Number
K180653
Device Name
Device, Neurovascular Embolization
Applicant
Spartan Micro, Inc
3167 Skyway Court
Freemont, CA 94539 US
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Contact
Mark Dias
Other 510(k) Applications for this Contact
Regulation Number
882.5950
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Classification Product Code
HCG
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More FDA Info for this Product Code
Date Received
03/13/2018
Decision Date
12/04/2018
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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