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FDA 510(k) Application Details - K111351
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K111351
Device Name
Set, Administration, Intravascular
Applicant
US INFUSION DBA TRUECARE BIOMEDIX
2003 NW 79TH AVE.
MIAMI, FL 33122 US
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Contact
AARON COMPTON
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Regulation Number
880.5440
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Classification Product Code
FPA
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More FDA Info for this Product Code
Date Received
05/13/2011
Decision Date
09/29/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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