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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
Other 510(k) Applications for this Contact
Regulation Number
880.5200
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Classification Product Code
NGT
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More FDA Info for this Product Code
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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