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FDA 510(k) Application Details - K080967
Device Classification Name
Device, Neurovascular Embolization
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510(K) Number
K080967
Device Name
Device, Neurovascular Embolization
Applicant
CORDIS NEUROVASCULAR, INC.
14201 NW 60TH AVENUE
MIAMI LAKES, FL 33014 US
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Contact
Amarilys Machado
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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
04/04/2008
Decision Date
05/02/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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