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FDA 510(k) Application Details - K053197
Device Classification Name
Device, Neurovascular Embolization
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510(K) Number
K053197
Device Name
Device, Neurovascular Embolization
Applicant
CORDIS NEUROVASCULAR, INC.
14000 N.W. 57TH CT.
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
11/16/2005
Decision Date
12/15/2005
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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