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FDA 510(k) Application Details - K032438
Device Classification Name
Saline, Vascular Access Flush
More FDA Info for this Device
510(K) Number
K032438
Device Name
Saline, Vascular Access Flush
Applicant
TYCO HEALTHCARE
15 HAMPSHIRE ST.
MANSFIELD, MA 02048 US
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Contact
DAVID OLSON
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
08/07/2003
Decision Date
06/30/2004
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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