FDA 510(k) Application Details - K090882

Device Classification Name Saline, Vascular Access Flush

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510(K) Number K090882
Device Name Saline, Vascular Access Flush
Applicant HOSPIRA, INC.
275 NORTH FIELD DR.
D-389, BLDG., H2
LAKE FOREST, IL 60045 US
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Contact KEITH DUNN
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Regulation Number 880.5200

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Classification Product Code NGT
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Date Received 03/31/2009
Decision Date 04/23/2010
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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