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FDA 510(k) Application Details - K153731
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K153731
Device Name
Set, Administration, Intravascular
Applicant
410 Medical Innovation, LLC
201 West Main Street, Suite 305
Durham, NC 27701 US
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Contact
Galen Robertson
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
12/28/2015
Decision Date
08/25/2016
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
N
Expedited Review
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