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FDA 510(k) Application Details - K100720
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K100720
Device Name
Set, Administration, Intravascular
Applicant
KAWASUMI LABORATORIES, INC.
1601 K STREET, N.W.
WASHINGTON, DC 20006 US
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Contact
SUZAN ONEL
Other 510(k) Applications for this Contact
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
03/15/2010
Decision Date
11/18/2010
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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