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FDA 510(k) Application Details - K121554
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K121554
Device Name
Set, Administration, Intravascular
Applicant
INFUSION INNOVATIONS, INC.
7514 GIRARD AVENUE
LAJOLLA, CA 92037 US
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Contact
BABAK NEMATI
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/25/2012
Decision Date
06/08/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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