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FDA 510(k) Application Details - K123344
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K123344
Device Name
Set, Administration, Intravascular
Applicant
KAWASUMI LABORATORIES, INC.
7401 104TH AVE. STE 160
KENOSHA, WI 53142 US
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Contact
CHRISTINA HENZA
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
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More FDA Info for this Product Code
Date Received
10/31/2012
Decision Date
03/07/2013
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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