FDA 510(k) Application Details - K090096

Device Classification Name Container, I.V.

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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
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Regulation Number 880.5025

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Classification Product Code KPE
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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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