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FDA 510(k) Application Details - K023089
Device Classification Name
Device, Neurovascular Embolization
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510(K) Number
K023089
Device Name
Device, Neurovascular Embolization
Applicant
BIOCURE, INC.
20310 SW 48TH ST.
FT. LAUDERDALE, FL 33332-1111 US
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Contact
JOHN GREENBAUM
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
09/17/2002
Decision Date
12/16/2002
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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