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FDA 510(k) Application Details - K020485
Device Classification Name
Container, I.V.
More FDA Info for this Device
510(K) Number
K020485
Device Name
Container, I.V.
Applicant
BAXTER HEALTHCARE CORP.
RT. 120 & WILSON RD.
ROUND LAKE, IL 60073 US
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Contact
MARY KONKOWSKI
Other 510(k) Applications for this Contact
Regulation Number
880.5025
More FDA Info for this Regulation Number
Classification Product Code
KPE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/13/2002
Decision Date
03/12/2002
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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