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FDA 510(k) Application Details - K153158
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K153158
Device Name
Set, Administration, Intravascular
Applicant
BAXTER HEALTHCARE CORPORATION
32650 N WILSON ROAD
ROUND LAKE, IL 60073 US
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Contact
GARY CHUMBIMUNE
Other 510(k) Applications for this Contact
Regulation Number
880.5440
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Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/02/2015
Decision Date
12/28/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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