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FDA 510(k) Application Details - K090096
Device Classification Name
Container, I.V.
More FDA Info for this Device
510(K) Number
K090096
Device Name
Container, I.V.
Applicant
BAXTER HEALTHCARE CORPORATION
1620 WAUKEGAN ROAD
MCGAW PARK, IL 60085 US
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Contact
NANETTE HEDDEN
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
01/15/2009
Decision Date
01/30/2009
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
Y
Expedited Review
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