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FDA 510(k) Application Details - K073419
Device Classification Name
Device, Neurovascular Embolization
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510(K) Number
K073419
Device Name
Device, Neurovascular Embolization
Applicant
RJ MEDICAL, INC.
4921 ROBERT J. MATHEWS PKWY
#2
EL DORADO HILLS, CA 95762 US
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JIM INNES
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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
12/05/2007
Decision Date
02/14/2008
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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