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FDA 510(k) Application Details - K024363
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K024363
Device Name
Set, Administration, Intravascular
Applicant
NEXUS MEDICAL, LLC
11428 LOSTWOOD LN.
SUITE B
RALEIGH, NC 27614 US
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Contact
JAMIE ABOURCHED
Other 510(k) Applications for this Contact
Regulation Number
880.5440
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Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/31/2002
Decision Date
02/19/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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